Biosafety

  • Biosafety is a term used to describe efforts to reduce and eliminate the potential risks resulting from biotechnology and its products.
  • After more than 12 years of safe use, it is fair to conclude that the inherent safety of the technology and the case-by-case safety assessments conducted by regulatory authorities around the world have ensured that foods from GM crops are as safe to eat as any food.
  • Planting GM cotton has improved yields by 10–30%, pesticide usage has fallen 50–80% and profitability for small farmers has improved significantly. Pesticide poisonings have decreased by about 75% among farmers using GM cotton.
  • Insect-resistant (Bt) maize has lower amounts of fumonisins than conventional maize because there is less insect damage to maize kernels on which the fungi can grow.
  • After years of research and evaluation on potential hazards, the published scientific research demonstrates that transgenic crops pose no environmental hazards unique to them.
  • Before any GM crop can be marketed, regulatory authorities must be satisfied that it will not make existing agricultural problems worse or create new ones.
  • The aim of any national biosafety legislation should be to provide a safety framework for the protection of humans, animals and the environment and to establish acceptable standards for risk assessment for the application of biotechnology.


Cartagena Protocol on Biosafety

The Cartagena Protocol on Biosafety is an international treaty governing the movements of living modified organisms (LMOs) resulting from modern biotechnology from one country to another. It was adopted on 29 January 2000 as a supplementary agreement to the Convention on Biological Diversity and entered into force on 11 September 2003.
The objective of the Protocol is to ensure an adequate level of protection in the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health, and specifically focusing on transboundary movements
To date, 156 countries have ratified or acceded to the Protocol. This includes the following 45 African countries: Algeria, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Democratic Republic of the Congo, Djibouti, Egypt, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Kenya, Lesotho, Liberia, Libyan Arab Jamahiriya, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Seychelles, South Africa, Sudan, Swaziland, Togo, Tunisia, Uganda, United Republic of Tanzania, Zambia and Zimbabwe.

For the full text of the Cartagena Protocol Click here


Precautionary Approach

In order to protect the environment, the precautionary approach is widely applied by countries according to their capabilities. This approach means that where there are threats of serious or irreversible damage, lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation

  • The Protocol covers LMOs to be intentionally introduced into the environment (advance informed agreement), and LMOs that are intended to be used as food or feed or for processing.
  • Parties to the Protocol must ensure that LMOs are handled, packaged and transported safely. The shipment of LMOs subject to trans-boundary movement must be accompanied by appropriate documentation specifying the identity of LMOs and contact point for further information.
  • Importing Parties make their decisions in accordance with scientifically sound risk assessments. The Protocol sets out procedures on how to conduct a risk assessment.
  • In case of insufficient relevant scientific information, the Importer may use precaution in making their decisions on import. Parties may also take into account socio-economic considerations in reaching decisions on import of LMOs.
  • Parties must adopt measures for managing any risks identified by the risk assessment, and must take necessary steps in the event of accidental release of LMOs.
  • The Protocol establishes a Biosafety Clearing-House for Parties to exchange information, capacity-building, financial mechanism, compliance and public awareness.


Adventitious Presence (AP)

The adventitious presence of impurities in agricultural commodities is the incidental presence of a material in a product at levels that could reasonably be expected to be present when using generally accepted agricultural and manufacturing practices.


Did You Know?

100% purity is impossible in the production of food, feed and seed. Agricultural commodities inevitably become inter-mixed to a small extent. This mixing results in the adventitious presence (AP) of impurities without affecting quality or sale ability of the crop. Lack of policies to address adventitious presence can lead to disruption of international trade. Acceptable AP levels must be science-based, feasible and non-discriminatory.

  • AP includes foreign matter or grain from other traded crops. AP is normally managed by applying mutually agreed quality standards and monitoring.
  • When applied to GM material, AP refers to the incidental presence of GM material in food, feed or grain at levels that are consistent with generally accepted agricultural and manufacturing practices.
  • A growing number of countries have established risk assessment procedures for approving the import of GM crops. However, many have not, as yet, adapted these processes to address the potential low level presence in their imports of GM material already authorised and being produced in other countries, but not yet approved (and therefore not intended to be present) in the importing country.
  • AP has the potential to disrupt trade as well as place significant burdens on the importing country’s authorities when such presence is detected.
  • The situation will become more prevalent as more and more new GM plants are developed and enter into commerce at different rates in different countries.
  • However, the situation is manageable. The control of AP is always preferred over other solutions. It is accepted best practice to seek authorisation from countries which import significant amounts of the crop in which a GM product has been introduced. The fact that authorizations are granted over different time scales is due to differences in the operation of different countries’ regulatory systems.
    International Guidance and/or Practices to address AP is essential

Despite this, adventitious presence of unauthorised events will inevitably occur from time to time, and when this happens importing countries will want to deal with it without compromising the safety or food security of their citizens. To do this, governments must be able to make decisions that recognise the realities of low level adventitious presence of GM material. This can best be achieved by:

  1. recognising the situations where a product has already been authorised in the country of origin, and accepting the risk assessment information that already exists, or
  2. building on existing, globally-recognised, science-based principles and guidelines for food/feed safety assessment that have been developed in order to harmonise procedures internationally.


AP and threshold costs

Once the safety of low levels of a particular non-approved GM material has been accepted, some countries may then choose to establish allowable levels or thresholds for the low level presence of the product.Â

Industry can implement different strategies and adopt various operational changes to reduce, but not eliminate, the likelihood of AP. However, it must be born in mind that each intervention yields different probabilities of success and incurs additional costs as development, production, distribution and inventory expenditures rise, and as total supplies of marketable seeds are reduced.

Government Regulations

International Regulations
International regulations become important when farmers plan to export or import genetically modified crops. In addition to the World Trade Organisation requirements for fair trade and pest and disease control, the Cartagena Protocol on Biosafety has specific requirements on movement of living GMOs.  For plants, this includes seed, grain, tubers, seedlings, or cuttings that could grow if planted in the importing country. The Cartagena Protocol requires that the importer of living GMOs must get advanced agreement from the importing country authorities for the movement of living GMOs into every country. This decision requires a risk assessment that considers safety to human health and to the environment, and so these decisions can take time.Â

For commercial farmers planning to export genetically modified seed, grain or plants, a lot of paper work has to precede the first shipment and several months may be needed for this. Once the first shipment has been approved, the Protocol does not require additional risk assessments, but some countries do.  It is up to the importer to ensure that each importing country’s requirements are met.

For smallholder farmers, the most likely ‘shipment’ of GM products across international borders will happen with informal movement of plant material and harvests between communities on each side of a national border. National regulators usually take informal movement across international boundaries into account when they first approve the planting of new GM crops. Some authorities require labelling for planting material, farmer education and sometimes the signing of farmer agreements, if they wish to limit the amount of planting material that moves informally across borders.

Resources

  1. Official site for the Cartagena Protocol on Biosafety (CBD)
    Outline: The Cartagena Protocol on Biosafety is an international agreement on biosafety. The Protocol applies to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health. This site provides background to the protocol, lists of countries that are Parties to the agreement and contact details in each country for applicants to obtain information on national approval processes. Click here
  2. Biosafety Clearing House – information on implementation of the Cartagena Protocol
    Outline: The Biosafety Clearing-House (BCH) is a mechanism set up by the Cartagena Protocol on Biosafety to facilitate the exchange of information on Living Modified Organisms (LMOs) and assist the Parties to better comply with their obligations under the Protocol. Global access to a variety of scientific, technical, environmental, legal and capacity building information is provided in all 6 of the UN languages. Click here
  3. An Examination of the Trade Issues Surrounding Genetically Modified Food. PEW. 2005
    Outline: This provides information on the trade dispute between the U.S. and the EU over agricultural biotechnology. It gives an overview of the history of the dispute between the U.S. and the EU over GM foods and crops, the impacts of the dispute on U.S. trade, and a summary of current EU regulations and its approval process. The Appendices provide additional background on other on-going international negotiations that may also affect trade in GM crops, as well as information about the evolving structure of EU governance. Click here



National Regulations
Most national governments have established regulations to help ensure the safe and responsible use of new technology, including genetic modification. Not all countries have implemented these regulations, however. National biosafety regulations generally require that research and development is carried out safely, that the products are tested thoroughly before they are used. In most countries, regulatory approval is required before some biotechnology products reach the market.Â

The safety of products of modern biotechnology generally falls under existing animal, food and plant regulations. Many countries have additional, specific biosafety regulations to ensure risk assessment reviews for genetically modified organisms and some countries include a socio-economic review to identify any social or economic risk that may result from the use of new products.Â

The wide range of products derived from genetic modification means that many government agencies are involved in safety assessments and approvals. For example, agricultural agencies review plant and animal safety; health agencies regulate food and medicine safety; environmental agencies review environmental impact; trade and industry agencies monitor economic impact; forestry agencies review the impact of genetically modified trees and tree products, etc.

Resources

  1. GMO approval process in South Africa
    Outline:Â This colourful poster outlines the approval process for GMOs in South Africa under regulation of the GMO Act (15, 1997). Additional guidance documents are available on the National Department of Agriculture website, but are not easy to find. Click here

  2. The biosafety regulatory process in the EU
    Outline: This animation details the current GM regulatory process in the EU and captures some of the frustration it generates. Click here

  3. Biosafety regulation in Canada and the U.S.
    Outline: This module provides basic information on the regulatory approaches taken by both Canada and the U.S., the roles and responsibilities of the different regulatory agencies, and access to specific regulatory guidelines and policy documents. Click here

  4. Country studies – National biosafety systems. IFPRI/ISNAR. 2000 to 2005
    Outline: This link takes the user to four national biosafety country studies for Uganda, Kenya, Egypt and Argentina. These examples provide insight into the different systems employed by different countries for the regulation of biotechnology products. Click here

  5. Australian biosafety regulation. OGTR
    Outline: This is the official website of the Office of the Gene Technology Regulator that functions within the Australian Government Department of Health and Ageing. The OFTR provides administrative support to the Gene Technology Regulator in the performance of her functions under the Gene Technology Act 2000. The Act provides a national scheme for the regulation of genetically modified organisms in Australia, in order to protect the health and safety of Australians and the Australian environment by identifying risks posed by gene technology, and by managing those risks through regulating certain activities with genetically modified organisms. Click here

  6. Cost of Regulating GMO’s in South Africa


Biosafety Resources

  1. A National Biotechnology Strategy for South Africa. (2001). Click hereÂ
  2. Genetically Modified Organisms Act (1997) (Act No. 15 of 1997). Click here
  3. Genetically Modified Organisms Bill. Click here
  4. National Environmental Management Act, 1998 (Act No. 107 of. 1998). Click here
  5. National Environmental Management: Protected Areas Act, 2003 (Act No.57 of 2003). Click here
  6. National Environmental Management: Biodiversity Act, 2004 (Act. No.10 of 2004). Click here
  7. Regulations governing the labeling of foodstuffs obtained through certain techniques of Genetic Modification. Click here
  8. Consumer Protection Act (Act No. 68 of 2008) Click here
  9. Biosafety is regulated by the Genetically Modified Organisms Act (1997) and its regulations. Click hereÂ
Overveiw of Biosafety in Africadownloads: 73 | type: ppt | size: 1 MB