Beneficial Organisms in Agriculture, Food and the Environment: Safety Assessment and Regulation

Although all available evidence suggest that Bti is a relatively safe biocontrol product, there is still limited knowledge regarding the potential germination of the bacterial spores and the interaction of Bti with indigenous Bacillus populations in treated wetlands. These questions will be addressed in a project where we use molecular markers and PCR methodology, focusing on the dynamics of the Bacillus bacteria the added as well as indigenous populations in both treated and untreated wetlands.

Safety assessment and regulatory issues

One study critically discussed the present and prospective future roles of the various regulatory systems that may be applicable to yeasts utilised in the food and feed chain, particularly for post-harvest biocontrol, with focus on conditions in Europe. Major conclusions were that relatively few biocontrol or biopreservation yeasts have as yet reached the market, that the possibility to regulate them as food additives similarly as for regulation of microbes as feed additives should be investigated, and that better knowledge about the dominant pathogenicity and virulence factors in opportunistic yeasts could possibly facilitate future safety evaluations of new yeast-based products.

New microbial biocontrol agents fall under the same legislation as chemical pesticides and need pre-market authorisation. Biotechnology Letters 29, Biological Control 48, Antonie van Leeuwenhoek 99, Annals of Applied Biology , Biocontrol Science and Technology 22, Vadim Kessler, - Deputy Head of Department: Mats Sandgren, - Administration manager: Jaana Evander , Statistics, biodiversity and environmental data. Collaborative centres and projects.

Safety assessment and regulatory issues | Externwebben

Follow us at Twitter. Follow us at Facebook. Regulations may cover the kind of information required for approval e. Phillips, in a IFPRI publication , points out that the GM crops currently commercialised are extensively traded internationally and that the countries growing them are also major exporters of these crops. Although many developing countries may not be actively involved in developing their own GM products, they may nevertheless wish to introduce regulations to cover the import of GM material or food.

Whereas European and North American countries have been at the forefront in developing regulatory systems for GMOs see e. Some countries have taken a cautious approach regarding regulation with the result that only few GMOs have been commercially released. Others instead have approved most of the new GM products for production and consumption. As a clear example of divergences in existing systems, Philips points out that some countries have adopted, or are developing, provisions requiring mandatory labelling of products derived from GMOs, whereas others have opted for voluntary labelling systems.

Development of a regulatory framework may be a costly, time-consuming process involving extensive consultation and effort.

The first concerns the legislative framework, including whether to use voluntary guidelines or legally binding regulations and whether to modify existing legal instruments or introduce new ones. The second concerns the criteria making a product subject to regulatory assessment e. The third element concerns transparency and public involvement in the decision making processes e. The fourth element is potentially quite contentious and concerns approaches to risk assessment and risk management.

This includes how to assess the risk from GMOs, how to decide when the human health and environmental risks posed by the GMOs are too great e. It also includes decisions on whether economic issues and market potential, social impacts or ethical concerns should be considered in the risk assessment and management.

In this context, it is important to note that the Cartagena Protocol on Biosafety see below , while asserting that assessments are to be undertaken in a scientific manner based on recognised risk assessment techniques, also recognises the right of importing countries to take into account socio-economic considerations, such as the value of biological diversity to its indigenous and local communities, in reaching a decision on import of GMOs.

A number of existing international agreements have direct relevance to GMOs and they can be of assistance to developing countries in establishing appropriate regulatory structures that deal with potential concerns while, at the same time, promoting harmonisation of national regulations at the international level.

In a recent study commissioned by FAO, Glowka reviewed the legal instruments available in this area. He showed that at the international level there is no single comprehensive legal instrument that addresses all aspects of GMOs or its products and that in the biosafety area i. The Cartagena Protocol on Biosafety, which seeks to protect biological diversity from the potential risks posed by living modified organisms LMOs, i. It has provided an important stimulus to the development of national GMO regulatory frameworks in developing countries.

As of 15 March , there were 33, 35, 17 and 28 countries from the Africa, Asia-Pacific, Central and Eastern Europe and Latin America and the Caribbean regions respectively participating in the project. A number of Codex Committees deal with matters related to GM foods. In , the Commission established the ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology to consider the health and nutritional implications of GM foods. The Commission is developing a series of guidelines covering areas such as the labelling of GM foods or food safety assessment of foods derived from GM plants.

The development and enforcement of a regulatory framework for GMOs may need to be co-ordinated within cross-sectorial national approaches to the management of biological risks associated with food and agriculture and the development of national institutions for these purposes. It covers food safety, plant life and health, animal life and health and the environment, including the introduction and release of GMOs and their products.

National regulatory and export certification systems are being challenged by large increases in the volume of food and agricultural products being traded internationally, by the expanding variety of imported products and by the growing number of countries from which these imports originate. Increased travel is also creating more pathways to spread pests, diseases and other hazards that are moving faster and further than ever before, both between and within countries.

Investments infrastructure and human resources in regulatory frameworks are high, with high recurrent costs. Improved co-ordination is therefore being sought among national bodies responsible for enforcing sanitary, phytosanitary and zoosanitary measures to better protect human, animal and plant life and health. Models for rationalising relevant regulatory functions among sectors are appearing in a number of countries.

For example, in Belize, food safety, animal and plant quarantine and environmental issues are dealt with by a single authority. When considering the kinds of GMO regulatory systems that might be appropriate for developing countries, it is important to consider that GMOs for food and agriculture are a very heterogeneous group, covering crops, fish, forest trees, livestock and micro-organisms, and thus they may present a range of different challenges.

The potential environmental risks from GM forest trees that may live years and grow to large heights differ, for example, from the release of a GM yeast to make bread. In addition, within each of these five sectors, GMOs may vary considerably, requiring different kinds of regulations.

Special regulations covering potential gene flow to their conventional counterparts may be necessary. For this reason, GMO commercialization is subject to a strict marketability requirement. GMOs intended for export are approved if and when they are accepted in Argentina's export market, primarily European countries. Otherwise, GMO varieties are not approved for commercialization.

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When exports are not a significant factor e. The goals of GMO regulatory frameworks are to ensure safe release and use of these products. While developing the frameworks, policy makers have to consider the play off between the need to minimise risk and to promote technology development. Strict regulatory frameworks will act to minimise the potential risks associated with GMOs but they may also act as a barrier to investments in GMO research and to the development of potentially useful GM products.

If the costs in terms of finances, time and human resources of complying with the regulations are substantial they will obviously act as a disincentive for parties with limited resources. As mentioned in previous Forum conferences e. Background Document to Conference 8 , the agricultural biotechnology field is currently dominated by developed countries and by the private sector in these countries, with the result that the research and the biotechnology products being developed or released are directed primarily to farmers in the developed and not developing countries and of richer and not poor farmers that can afford the products.

Establishment of strict regulatory regimes in developing countries may therefore exacerbate this situation as they have fewer available resources. This is expressed dramatically by Nap et al. Excessive regulatory reviews will frustrate and curtail research and application to such an extent that only a few large multinational companies can afford to make progress.

New methodology for evaluation of potential toxicity in microbes

In this manner, over-regulation will help to promote a situation that is a concern of many: This trend is already clearly apparent and may result in the creation of a single or a few companies dominating world food production and increasing world dependence".

On the other hand, relaxed regulations, allowing rapid and easy approval of GMOs, may not effectively protect citizens and the environment from potential risks. Policy makers have therefore to carefully balance these costs and benefits. Costs and benefits have also be weighed up when considering the monitoring and enforcement aspects of GMO regulations. Strict measures, involving frequent, long-term and careful checks and inspections of GMOs, strain the limited resources of developing countries.

Relaxed measures may, on the other hand, encourage parties to flout the rules. This conference considers the subject of regulating GMOs, for food and agriculture, in developing countries including transition countries. More specifically, some items we would like to see discussed here are:.

Where we work

How appropriate is it to use environmental and food safety data from one country when seeking approval for commercialisation in a second country? Is the sector involved agro-industry, crop, fisheries, forestry or livestock important in this context? Given this situation, and given the limited resources financial and personnel available, what priority should they give to the development of regulatory frameworks for GMOs?

For developing countries with limited resources wishing to establish a GMO regulatory framework, what are the key areas that should first be prioritised? How can monitoring be carried out efficiently in this situation? Are different sets of regulations required for each sector? When submitting messages which should not exceed words , participants are requested to ensure that their messages address some of the above elements.

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