INTERNATIONAL BIOSAFETY PROTOCOLS

BIOSAFETY:

Biosafety is one term that is used to describe the policies and procedures adopted to ensure the environmentally safe application of modern biotechnology. It is a term that is gaining wider currency as more countries seek to benefit from the application of modern science in

i. Agriculture

ii. Medicine

iii. The environment, without endangering public health or environmental safety.

INTERNATIONAL BIOSAFETY PROTOCOLS:

The Biosafety Protocol seeks to protect biological diversity from the potential risks. The Biosafety Protocol makes clear that products from new technologies must be based on the precautionary principle. For example let countries ban imports of a living modified organism if they feel there is not enough scientific evidence that the product is safe. It will ensure that countries do not neglect biosafety requirements in order to promote their biotechnology industries. It will help the developing countries to formulate national biosafety regulations. In accordance with the provisions of its Article 37, the Protocol entered into force on 11 September 2003

NEED FOR INTERNATIONAL BIOSAFETY:

The need for international biosafety guidelines was accepted at the 1992 Rio Earth Summit. After initial opposition from some developed countries, the need for an international protocol is widely accepted. Developing countries by and large, prefer a comprehensive protocol, covering research, transport, and use of the GMOs.

The developed countries also oppose a strict protocol as they fear that this will affect the development of biotechnologies in their countries. A compromise between the developed countries was reached in 1995. According to this protocol will regulate the transport of GMOs and not their use. While a group of developing countries wanted to expand the coverage of the protocol to include the use of GMOs.

In the absence of a comprehensive international protocol, the use of GMOs will need to be regulated by national biosafety regulations. Presently, very few developing countries have such regulations which include china, India, and the Philippines. Some Latin American countries are in the process of preparing biosafety regulations.

BIOSAFETY GUIDELINES AND REGULATIONS:

• To minimize the probability of occasional release of GMOs
• To ban the deliberate release of such organisms in to the environment.
• In India, DBT has evolved “the recombinant DNA safety guidelines to exercise powers conferred through the environmental protection act 1986

1. For the manufacture
2. Use
3. Import & export
4. Storage of hazardous microorganisms

BIOSAFETY GUIDELINES FOR LABORATORIES:

• Food storage, eating, drinking and smoking are prohibited in lab.
• Mouth pipetting is prohibited
• Laboratory coats are obligatory and should be removed when exiting the lab.
• Working surfaces must be decontaminated using soap and alcohol after each working day.
• Waste products must be decontaminated by incineration or by autoclaving.
• Frequent hand wash is obligatory (atleast one hand wash sink should be available).
• Avoid contact with GMO's and other exotic biological agents, Disposable gloves should be worn when handling such items.

• Laboratory door should be closed at all times.
• Working with fume-producing chemicals must be under the laboratory hood.
• Biohazard warning signs should be always posted in labs.
• The international biohazard warning symbol and sign must be displayed on the doors of the rooms where microorganisms of risk or higher risk groups are handled.
• Only authorized persons should be allowed to enter the laboratory working areas.
• Laboratory doors should be kept closed.
• Children should not be authorized or allowed to enter laboratory working areas.
• No animals should be admitted other than those involved in the work of the laboratory.

LABORATORY DESIGN AND FACILITIES:

In designing a laboratory and assigning certain types of work to it, special attention should be paid to conditions that are known to pose safety problems. These include:

• Formation of aerosols
• Work with large volumes and/or high concentrations of microorganisms
• Overcrowding and too much equipment
• Infestation with rodents and arthropods
• Unauthorized entrance
• Workflow: use of specific samples and reagents
  

HANDLING AND DISPOSAL PROCEDURES FOR CONTAMINATED MATERIALS AND WASTES:

• Non-contaminated (non-infectious) waste that can be reused
• Contaminated (infectious) “sharps” – hypodermic needles, scalpels, knives and broken glass; these should always be collected in puncture-proof containers fitted with covers and treated as infectious
• Contaminated material for decontamination by autoclaving and thereafter washing and reuse or recycling
• Contaminated material for autoclaving and disposal
• Contaminated material for direct incineration.

BIOSAFETY GUIDELINES FOR FIELD TRIALS (SMALL-SCALE FIELD TESTING:

• Field experiments with exotic plant pest and pathogens are prohibited.
• Plants must be prevented from spreading pollen by the removal of flowers
• If flowers are needed for testing and further experimentation, the inflorescence flowers must be covered before maturation.
• Suitable plot isolation must be provided avoiding pollen transmission to other near plots.
• Entry of plots by unauthorized personnel is prohibited.
• Special protective measures should be taken to ensure complete isolation of harvested plant parts.
• Plots must be protected from the entry of animals or insects using boarder rows.

BIOSAFETY REGULATIONS IN INDIA:

Biosafety regulations were first prepared in India in 1990 & revised in 1994. The regulations cover both the research and field trials of GMOs. Furthermore, they cover both the locally developed GMOs and imported GMOs. The regulations are implemented by three committees.

INSTITUTIONAL BIOSAFETY COMMITTEE (IBSC):

All institutions intending to undertake research activities involving genetic manipulation of microorganisms are required to set up IBSCs. IBSC includes representatives from the concerned institution, the department of biotechnology (DBT) and a doctor. The researchers are required to inform the institute’s IBSC of any experiment with biosafety implications. It is also responsible for training of researches on biosafety.

REVIEW COMMITTEE ON GENETIC MANIPULATION (RCGM):

The RCGM functions under the DBT and monitors all ongoing research with biosafety implications. The committee also issues clearance for import and export genetic material required for research and training purposes.

GENETIC ENGINEERING APPROVAL COMMITTEE (GEAC):

GEAC functions under the ministry of environment and is responsible for biosafety in the cases of

a) Field trials and large scale (commercial) release of GMOs.

b) Production, sale, import, or use of genetically engineered products

c) Import, export, transport, handling, and use of GMOs.

BIOSAFETY REGULATIONS IN INDIA:

A complete list of research with biosafety implications being carried out in India is not available publicly. It is, therefore, not possible to make definite comments on the potential risks associated with research on GMOs in India. Our information, however, suggests that most of the research on GMOs in India is at an early stage.

BIOSAFETY REGULATIONS IN DEVELOPED COUNTRIES:

The steps to regulate the release of GMOs were first taken in developed countries in the 1980s. A biotechnology risk assessment research program was launched by the U.S in 1986. The most developed countries have formulated rules to regulate the use & release of GMOs. Recently there has been a trend towards relaxation of biosafety rules in developed countries. UK is in the process of relaxing the rules regulating the release of GMOs. It is however also dictated by the fear that strict regulations will slow down the development of local biotechnology industries and make them uncompetitive.

CARTAGENA PROTOCOL ON BIOSAFETY:

The Cartagena Protocol on Biosafety is an international agreement on biosafety, as a supplement to the Convention on Biological Diversity.

OBJECTIVE OF THE PROTOCOL:

The objective of the Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of LMOs. LMO resulting from modern biotechnology' that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements (Article 1 of the Protocol, SCBD 2000).

LIVING MODIFIED ORGANISMS (LMOS):

Living modified organisms (known as LMOs) resulting from modern biotechnology are broadly equivalent to genetically modified organisms. The difference between an LMO and a GMO is that a Living Modified Organism is capable of growing, and typically refers to agricultural crops. Genetically Modified Organisms include both LMOs and organisms which are not capable of growing, i.e. are dead.

THE PROTOCOL AND THE PRECAUTIONARY APPROACH:

Article 1, indicating that the objective of the Protocol is "in accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development"; Article 10.6 and 11.8, which states "Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of an LMO on biodiversity. Annex III on risk assessment, which notes that "Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk."

WHAT DOES THE PROTOCOL COVER?

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 (Article 4 of the Protocol, SCBD 2000).

MAIN FEATURES OF THE PROTOCOL:

The Protocol promotes biosafety by establishing rules and procedures for the safe transfer, handling, and use of LMOs, with specific focus on transboundary movements of LMOs. It features a set of procedures including one for LMOs that are to be intentionally introduced into the environment called the advance informed agreement . One for LMOs that are intended to be used directly as food or feed or for processing. Parties to the Protocol must ensure that LMOs are handled, packaged and transported under conditions of safety.

BIOSAFETY CLEARING-HOUSE:

The Protocol established a Biosafety Clearing-House (BCH), in order to facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, living modified organisms. To assist Parties to implement the Protocol (Article 20 of the Protocol, SCBD 2000). It was established in a phased manner, and the first meeting of the Parties approved the transition from the pilot phase to the fully operational phase, and adopted modalities for its operations.

WHAT IT DOES:

The Protocol establishes an Internet-based "Biosafety Clearing-House.It creates an advance informed agreement (AIA) procedure. It requires shipments of LMO commodities, such as maize or soybeans that are intended for direct use as food, feed, or for processing, to be accompanied by documentation stating that such shipments "may contain" living modified organisms and are "not intended for intentional introduction into the environment

WHAT IT DOES NOT DO:

The Protocol does not address food safety issues. It does not require segregation of commodities that may contain living modified organisms. It does not subject commodities to the Protocol's AIA procedure, which would significantly disrupt trade, without commensurate benefit to the environment. The Protocol does not require consumer product labeling.

KEY PROVISIONS OF THE BIOSAFETY PROTOCOL:

A. ADVANCE INFORMED AGREEMENT (AIA) PROCEDURE:

The Protocol's AIA procedure, in effect, requires an exporter to seek consent from an importing country prior to the first shipment of a living modified organism (LMO) intended for introduction into the environment . The AIA procedure does not apply to LMO commodities that are intended for food, feed, or processing. Importers are to make decisions on the import of LMOs intended for introduction into the environment based on a scientific risk assessment and within 270 days of notification of intent to export.

TRADE WITH NON-PARTIES:

The Protocol states that the "transboundary movement of living modified organisms between Parties and non-Parties shall be consistent with the objective of this Protocol. Therefore, although the Protocol only requires trade between Parties and non-Parties in LMOs to be consistent with the "objective" of the Protocol. We anticipate that, as a practical matter, firms in non-Party countries wishing to export to Parties will need to abide by domestic regulations put in place in the importing Parties for compliance with the Protocol.