SEPTEMBER 11, 2010

By M Manimaran, IRS

THE rapid urbanization, industrialization and the allied factors have resulted in shrinkage of cultivable land through out the world. The quantum of agricultural produce from the conventional farming is not commensurate with the ever-increasing population worldwide resulting in under nourishment and the hungry millions. In this scenario, the rapid strides of biotechnological innovations like GM foods etc., augurs well and may be an answer for the hungry millions. But most countries around the world banned the GM food which includes certain African states for fear of environmental risk. In India Dr.Bhargava a genetic scientist warned against GM foods like Deritos corn chips sold against law without proper trials. He lamented that BT cotton is being cultivated without a comprehensive risk assessment having been conducted. He claimed, “We do not need Bt cotton or GM foods because no advantage is being conferred by these foods and the harm that may cause has still to be properly assessed. Most countries around the world have imposed ban on these foods, but the Indian Government refuses to listen”. He also warned that the Government 1000 cattle that foraged on the remnants of BT cotton plants in some districts of Andhra Pradesh over the last few years. An another aspect highlighted by him was how the Monsanto-Mahyco's new studies have shown a gene flow of up to 15-20 metre ( that is ,the Bt gene can affect non Bt plants that 10-20 metres away) in case of Bt brinjal 10 metres for Bt cotton. The mad cow's disease and the human form of mad cows disease is still a grim reminder to the people around the world especially the Europeans and because of that hundreds of people died who consumed the beef of the mad cows that were fed to prions. In the GM food crops the genetic structure is changed artificially. Due to these reasons and in the absence of any concrete opinion from the scientific community one need to tread cautiously in order to protect environment, humans, animals, plants etc and so the bio-safety is the main concern around the world.

Definition of bio-safety :

The bio-safety means the safe development of biotechnology products and their safe application resulting from the existence of an effective mechanism for the safeguard of human and animal health, safe agricultural production, safe industrial production, safeguard of the natural plant and animal species, (flora and fauna) and the environment from negative consequences from the practice and applications of biotechnology and its products. The concept of biotechnology is the integration of the biological, biochemical, biophysical and bioengineering sciences in order to enable the use of organs, cells, bimolecular, (nucleic acids, enzymes and proteins) and other derivatives including molecular analogues for commercial or industrial applications. Biotechnology products have applications in agriculture, commodity production, human and animal health, molecular farming, drug production etc. Biosafety concerns are more appropriately related to modern Biotechnology or more precisely, Recombinant biotechnology (r-DNA) Technology. R-DNA technology is the transfer of genes from one organism, across a species boundary, to another organism, which results in the expression of the transferred genes in the new host to produce a new desired product, making the new host a transgenic organism, called a genetically modified organism (GMO) or a living modified organism (LMO). In the agricultural front there are number of biotechnology products which are already on the commodity markets. Viz., Bt maize; Bt cotton, Transgenic tomato, Transgenic Soya bean, Transgenic potato etc.

Historical background and origin of GMOs

The knowledge on which the techniques of genetic modification are based dates from the 1950s, when James Watson and others discovered the structure of DNA. This has opened up the possibility that the genetic coding of organisms which could be altered to give them new characteristics that natural evolution or selective breeding could not produce. In the 1970s, it became possible to isolate individual genes, refashion them and copy them in cells, huge commercial possibilities opened up. Ways of applying this new technology to medicine were developed quite rapidly. The commercial use of genetically modified organisms (GMOs) in agriculture is currently limited almost exclusively to different varieties from four crop species. These include: soybeans, maize (corn), oilseed rape (canola), and cotton .

International Responses and Regulation:

There are four key international instruments that are relevant to the regulation of modern biotechnology, these include:

Convention on biological diversity (CBD)

The CBD was the first international legal instrument to indicate that biotechnology was a matter of concern for the international community and that consideration should be given to adopting regulations.

The CBD is the legal regime for the conservation and sustainable use of biodiversity. The CBD was adopted in 1992 at the UNCED in Rio de Janeiro and was opened for signature on 5th June 1992 and entered into force on the 29 December 1993.

The aim of the CBD is to conserve biological diversity, the sustainable use of its components and the fair and equitable sharing of benefits arising out of the Utilization of genetic resources.

The CBD encourages the parties to develop national strategies, plans and programmes for the conservation and sustainable use of biological diversity.

The CBD further makes a provision urging the parties to consider need for a bio-safety protocol.

THE CARTAGENA PROTOCOL ON BIOSAFETY :

The Cartagena protocol is one of the international agreements that have been concluded to regulate the trans-boundary movement of genetically-modified Organisms (GMOs). The Cartagena Protocol provides special rules and procedures for international regulation of GMOs. The Protocol has its base in concerns of developing countries, that because of capacity limitations, they will not be able to control effectively which GM products cross their borders or regulate adequately their use. The Protocol is generally considered to have a more developing country-orientated position. The issue of bio-safety emerged for the first time in the context of a global legally binding instrument during the negotiations of the Convention on biological diversity (CBD). GMOs constitute a potential risk to the biological diversity but the CBD does not specifically deal with the issue of GMOs. However, it is of direct relevance to the creation of protection regimes for all biological resources and biodiversity generally at the international level.

In 1994, at the first meeting of the Conference of the parties (COP),

preparatory works were authorized in this regard based on these findings. The second COP set up the open-ended ad hoc working group on bio-safety with a view to draft a protocol, which would especially focus on the trans-boundary movement of GMOs. i sixth meeting , held in 1999 at Cartagena . However, the negotiators failed to reach a compromise at that meeting in February 1999 in Cartagena , Columbia from where incidentally the Protocol derived its nomenclature. Thus, the meeting had to be suspended. After informal meetings the Ex-COP was eventually resumed in January 2000 in Montreal where the Protocol was finally adopted on 29 January 2000

Scope and application:

The scope of the Cartagena Protocol is established under Article 4, which specifies under what circumstances a party must apply the provisions of the protocol by specifying the activities and organisms to which the protocol applies. Article 4 of the Cartagena Protocol states that, the Cartagena Protocol shall apply to the trans-boundary movement, transit, handling and use of all living modified organisms (LMOs) that may have adverse effects on the biological diversity, taking also into account the risks to human health. Article 6 provides a more limited exemption as it exempts LMOs in transit and LMOs destined for contained use from the application of the AIA procedure.

Scope of application of the AIA procedure :

The scope of application of the AIA procedure is laid out in Article 7(1) and 7(2).

Article 7(1) states that the AIA procedure shall apply prior to the first intentional Trans-boundary movement of LMOs for “intentional introduction into the environment”. In practical terms the AIA procedure will apply particularly to the growing of agricultural crops, the release of fish and of modified microorganisms.

Notification

Article 8 addresses the first step in the AIA procedure, which is the notification of the proposed trans-boundary movement to the Party into which the LMO is to be imported. According to Article 8 (1), the exporting country or the exporter shall notify the importing country prior to the first intentional trans-boundary movement of an LMO that falls within the scope of the AIA procedure under Article 7(1). The notification must take place before the first trans-boundary movement of the LMO into the Party of import is initiated. The notification shall contain, at a minimum, the information specified in Annex I. which covers a wide range of information, which may be loosely grouped into three categories: 1) The information concerning the LMO itself aimed at providing the importing country with factual information; 2) The regulatory status in the exporting party intended to inform the country of import about the cost benefit assessment of the state of origin; 3) The suggested methods for the safe handling and use.

Acknowledgement of receipt

Article 9 requires the importing state to acknowledge receipt of the information to

the notifier within 90 days of its receipt.

Decision procedure

Article 10 of the Protocol sets out the procedure to be followed by the party of import in reaching its decision. This decision is whether to allow the first trans-boundary movement of a LMO into its territory. Article 10(2) provides that the importing state shall, together with the acknowledgement of receipt, notify to the exporting state as the requirement applies whether or not, under the domestic law of the party of export, it is the party of export itself or the exporter who is required to notify the party of import of the proposed trans-boundary movement of LMOs.

As per Article 9 (1) the confirmation of the date of receipt of the notification is important and in that it is this date which marks the beginning of the 270-day period within which the party of import should reach its import decision under Article 10. The export is allowed only in cases where written consent has been notified by the importing country.

Notification of National Regulations

According to Article 11(1), a party that makes a final decision regarding domestic use of a LMO-FFP that may be subject to trans-boundary movement shall inform the parties through the ‘Bio-safety Clearing-House' (BCH) system within 15 days of reaching that decision.

Lastly, Article 11 (8) explicitly allows the parties to take a precautionary approach to decision-making on imports. In addition, the general rules concerning risk management and socio-economic considerations are also applicable.

Handling, transport, packaging and identification

Article 18 addresses the handling, transport, packaging and identification of LMOs and has two main functions. 1) To ensure that LMOs are handled and moved safely to avoid adverse effects on biodiversity and human health. 2) To provide information to those handling LMOs and to the party of import.

Risk Assessment and Management

Article 15 establishes the basic requirements for risk assessment under the Protocol, and refers to Annex III for further guidance. Article 15 and Annex III are, therefore, closely connected. The Protocol requires that decisions regarding the import of LMOs for intentional introduction into the environment to be taken in accordance with a risk assessment.

As far as India is concerned the protocol entered into force from September 11, 2003. As of May, 2006, 132 countries have ratified the protocol.

ANNEX–I TO CARTAGENA PROTOCOL ON BIOSAFETY (in brief)

Name, address and contact details of the exporter.

Name, address and contact details of the importer.

Name and identity of the living modified organism, as well as the domestic classification, if any, of the bio-safety level of the living modified organism in the State of export and connected particulars.

ANNEX–II TO CARTAGENA PROTOCOL ON BIOSAFETY (in brief)

The name and contact details of the applicant for a decision for domestic use.

The name and contact details of the authority responsible for the decision.

Name and identity of the living modified organism and other connected particulars.

ANNEX–III TO CARTAGENA PROTOCOL ON BIOSAFETY RISK ASSESSMENT

Objective

The objective of risk assessment, under this Protocol, is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health.

Use of risk assessment

Risk assessment is, inter alia , used by competent authorities to make informed decisions regarding living modified organisms.

The role of Customs officers :

As per Article 7, Customs is also notified as a competent authority and so it is bound to regulate the import/ export of such products in the borders. They also have to carry out the inspection of the LMOs/GMOs.

All the documents for export/Imports like bills of entry, Shipping bills, Invoices, Packing lists, Declarations if any made by the party and other relevant certificates issued by the officials of plant quarantine, food control etc should be meticulously examined in order to see whether it is meant for the intended purpose like contained use, projects etc and to thwart possible mischief by the unscrupulous elements.

The customs department also has to identify the LMOs /GMOs and their status at the time of export and import.

Lastly in case if such LMOs/GMOs move into any other country's border clandestinely it has to be stopped and action has to be initiated for detention /seizure of the same and follow up action under customs Act.

Source: IUCN-FIELD-WRI, An explanatory guide to the Cartagena protocol on bio-safety (2002)

(The views expressed are personal of the author)