Environmental Science

LESSON .29. Biosafety And Risk Assessment

Agenda 21, adopted during the United Nations Conference on the Environment and Development, addresses the pressing problems of today and also aims at preparing the world for the challenges of the next century. It reflects a global consensus and political commitment at the highest level on development and environment cooperation. Its successful implementation is first and foremost the responsibility of Governments. Biosafety emerged as a global priority in chapter 16 of Agenda 21, and in Articles 8(g) and 19 of the Convention on Biological Diversity. Risk analysis must be undertaken to predict the occurrence of negative impacts on the environment and human and / or animal health. These assessments allow us to define predictive measures to mitigate or avoid the adverse effects that could result from potential or identified hazards.

The backbone of the practice of biosafety is risk assessment. While there are many tools available to assist in the assessment of risk for a given procedure or experiment, the most important component is professional judgement. Risk assessments should be performed by the individuals most familiar with the specific characteristics of the organisms being considered for use, the equipment and procedures to be employed, animal models that may be used, and the containment equipment and facilities available.

Risk: It is defined as the probability of harm. Risk analysis follows a structured approach with three distinct but closely related steps:-

1. Risk assessment

2. Risk management

3. Risk communication

In addition, factors related to risk prevention, reduction and remediation should also be considered.

Risk assessment:

Following Codex Alimentarius, noted in the Food and Agriculture Organisation’s  biotechnology glossary (FAO, 2001), risk assessment is defined as “a scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment and (iv) risk characterization. Risk assessment evaluates and compares the scientific evidence regarding the risks associated with alternative activities.

Risk management:

Risk management is “the process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practice, and if needed, selecting appropriate prevention and control options”. Risk management develops strategies to prevent and control risks within acceptable limits and relies on risk assessment. In addition to the scientific assessment, it also takes into consideration various factors such as social values and economics.

Risk communication:

Risk communication is defined as “the interactive exchange of information and opinions throughout the risk analysis process concerning risks, risk related factors and risk perception, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions. Risk communication involves an ongoing dialogue between regulators and the public about risk and options to manage risk so that appropriate decision can be made. Risk assessment should be carried out on case by case basis.

There are several ways to complete a risk analysis (Conner et al. 2003; EFSA, 2004; FAO, 2003; Krayer von Krauss et al. 2004). It has been generally accepted that details of risk assessment procedures may vary from case to case but there are few logical steps that need to be followed:

1. Identification of potential adverse effects on human health or environment

2. An estimation of likelihood of these adverse effects

3. An evaluation of identified risks

4. Considerations of appropriate risk management strategies

5. Assessment of overall potential environmental impact and consequences

6. A recommendation as to whether or not the risks are acceptable or manageable.

The evaluation is scientifically based, where parameters that comprise a risk (such as hazard and exposure) are submitted to quantitative analysis (Funtowics et al., 1999; NRC, 2002; OECD, 2005). However, there is no widely accepted and specific risk assessment method for the evaluation of genetically modified plants that drawn on quantifiable parameters and allows for a comparative analysis among different technologies.

BIOSAFETY LEVEL:

A biosafety level is the level of the biocontainment precautions required to isolate dangerous biological agents in an enclosed facility. There are four biosafety levels. Each level has specific controls for containment of microbes and biological agents. The primary risks that determine levels of containment are infectivity, severity of disease, transmissibility, and the nature of the work conducted. Origin of the microbe, or the agent in question, and the route of exposure are also important.

Biosafety Level 1: It is suitable for work involving well-characterized agents not known to cause disease in healthy adult humans, and of minimal potential hazard to laboratory personnel and the environment.

Biosafety Level 2: Risk Group 2 infectious agents are pathogens that can cause human or animal disease. But, under normal circumstances, are unlikely to be a serious hazard to laboratory workers, the community, livestock, or the environment . Level 2  infections are not considered to be a serious hazard. They are a moderate individual risk and limited community risk.

Biosafety Level 3: Risk Group 3 infectious agents are pathogens that usually cause serious human or animal disease, or which can result in serious economic consequences, but do not ordinarily spread by casual contact from one individual to another (high individual risk, low community risk), or that can be treated by antimicrobial or antiparasitic agents.

Biosafety Level 4: Highly toxic/infectious agents. Agents that are at a very high risk for forming infectious aerosols.

Elements of a Biosafety system:

• The guidelines formulated should be transparent, science-based, and flexible. The guidelines clearly define the structure of the biosafety system, the roles and responsibilities of those involved, and how the review process is to operate.

• Competence and confidence must be built in the people who are involved. The people are knowledgeable and well-trained, confident in their ability to make decisions, and supported by their institutions.

• The biosafety review process must be appropriate. The review process is based on up-to-date scientific information; focuses on specific combinations of crop, gene, and environment; promotes appropriate risk management practices; and balances risks against benefits.

• There should be means of ensuring feedback so that the system improves through experience. Feedback mechanisms are used to incorporate new information and revise the system as needed.

Bio-safety and Cartagena Protocol:

The Cartagena Protocol on Bio-safety is the first international regulatory framework for bio-safety, negotiated under the aegis of the Convention on Biological Diversity (CBD). Bio-safety sets out a comprehensive regulatory system for ensuring the safe transfer, handling and use of Living Modified Organisms (LMOs) with a focus on transboundary movement. The Protocol deals primarily with LMOs that are to be intentionally introduced into the environment (such as seeds, trees or fish) and with genetically modified farm commodities (such as corn and grain used for food, animal feed or processing). It does not cover pharmaceuticals for humans addressed by other international agreements and organizations or products derived from LMOs, such as cooking oil from genetically modified corn.

India ratified the Protocol on January 23, 2003 and the Ministry of Environment & Forests (MoEF) is the nodal ministry for implementation of Cartagena Protocol. MoEF has taken several initiatives to meet its obligations to the Protocol including capacity building of various stake holders for its effective implementation in the country. MoEF is implementing a GEF- World Bank funded Capacity Building Project on Bio-safety with an objective to strengthen of regulatory framework, particularly on transboundary movement of living modified organisms (LMOs)/ genetically modified organisms (GMOs), risk assessment and management, training and human resource development and information sharing.

Biosafety Regulatory Framework in India:           

The Ministry of Environment and Forests (MoEF) has notified the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989 (known as ‘Rules, 1989’) under the Environment (Protection) Act, 1986. These rules and regulations cover the areas of research as well as large scale applications of Genetically Modified Organism (GMOs) and products made there from throughout India.  The rules also cover the application of hazardous microorganisms which may not be genetically modified.  Hazardous microorganisms include those which are pathogenic to animals as well as plants. 

These rules also define the competent authorities and composition of such authorities for handling of various aspects of the rules.  Presently there are five competent authorities  that is,

• Institutional Biosafety Committees (IBSC),

•  Review Committee of Genetic Manipulation (RCGM),

• Genetic Engineering Approval Committee (GEAC),

• State Biotechnology Coordination Committee (SBCC) and

• The District Level Committee (DLC).

The RCGM established under the Department of Biotechnology (DBT) supervises research activities including small scale field trials, whereas approvals for large scale releases and commercialization of GMOs are given by the GEAC, established under the MoEF. The SBCCs and DLCs have a major role in monitoring.

BIOSAFETY RESEARCH REGULATORY PROCESS IN INDIA:

• RCGM is the regulatory authority for Biosafety Research Level I (BRL I) trials. These trials are limited to no more than one acre per trial site location.

• GEAC is the regulatory authority for Biosafety Research Level II.(BRL II) trials. Size and number of trials will depend on case by case.

•  Minimum of three seasons/ years BRL trials are required for generating biosafety data for an event

	Option 1	Option 2
Year/season I	BRL I	BRL I
Year/season II	BRL I	BRL II
Year/season III	BRL II	BRL I

While the debate on transgenic foods has not reached the heights it has in Europe and other countries, a public interest litigation (PIL) on bio-safety of Genetically Modified Organism (GMO) has come to the rescue of anti-GM campaigners. The PIL demanded, among other things, a stop to all field trials of GM crops in the country. In its first order dated May 1, 2006, the Supreme Court had directed that till further orders, field trials of genetically modified crops should be conducted only with the approval of the Genetic Engineering Approval Committee (GEAC). Earlier they used to be approved by the Review Committee on Genetic Manipulation (RCGM) under the Department of Biotechnology. The PIL contented that RCGM did not have the jurisdiction since it was under a department that was primarily responsible for the promotion of such untested biotechnology. In another order of September 22, 2006, the apex court said that while it was not inclined to direct stoppage of field trials, it ordered the GEAC to withhold approvals.