Dr. Amita Prasad, Additional Secretary, Ministry of Environment, Forest and Climate Change

Government of India

Biosafety Capacity Building: Initiatives and Way Forward

GMOs and Biosafety Regulations

Significant advances have taken place in last three decades towards development of genetically modified organisms (GMOs).

GMOs and products thereof are being used for diverse applications in healthcare, agriculture, process industry etc.

Ensuring biosafety of GMOs and products thereof is commitment of the national governments.

National and international regulations are in place to deal with biosafety aspects.

India’s biosafety regulatory framework is based on “Rules for manufacture, use/import/ export & storage of hazardous micro organisms/ genetically engineered organisms or cells, 1989” notified under the Environment (Protection) Act, 1986

The Ministry of Environment, Forest and Climate Change is the nodal Ministry responsible for implementation of the Rules, 1989. The Department of Biotechnology and state governments are also involved.

The Rules are implemented through six statutory committees with Genetic Engineering Appraisal Committee as the apex committee.

Biosafety Regulatory Framework in India

As the genes are derived from various

organisms, concerns raised regarding safety of such organisms since the advent of technology in 1975 and guidelines/regulations put in place

First GMO derived product Insulin approved

in 1982 and first GM crop (tomato)approved in 1996 in USA

Applications in healthcare widely accepted, however biosafety concerns in applications in agriculture

Biosafety Concerns

Regulatory Approval of a GM crop

Comprehensive biosafety research data to demonstrate:

Food and feed safety Environmental safety Social and economic benefits

Safety Assessment Process • The development process of a GM crop is a step wise

process consisting of laboratory research, greenhouse studies, field trials and safety studies.

• Guidelines have been issued by DBT and MoEFCC to deal with various steps in this development process.

• International guidance available, prepared through years of deliberations and participation of many countries

• Food safety guidance notified by Codex Alimentarious (FAO/WHO) and Environmental Risk Assessment under the Cartagena Protocol on Biosafety.

• Socio-economic considerations are country specific and location specific; international discussions still underway.

Cartagena Protocol on

Biosafety

What is Cartagena Protocol on Biosafety (CPB)?

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international treaty governing the movements of living modified organisms (LMOs) resulting from modern biotechnology from one country to another.

Key Features:

An agreement between different countries negotiated under the

Convention on Biological Diversity (CBD)

Adopted on 29 January 2000 after 4 years of intense

negotiations

Entry into force on 9 September 2003 and India ratified this

Protocol on September 11, 2003

Till date 170 countries have ratified this Protocol

Cartagena Protocol on Biosafety and Socio-economic Considerations

Article 26 of the Cartagena Protocol on Biosafety enables Parties to consider socio-economic considerations (SECs) in the decision making.

There have been series of online discussions, meetings and work by an Ad-hoc Technical Expert Group to deliberate on SECs.

These reports will be discussed in the forthcoming Eighth Conference of Parties Serving as Meeting of Parties (COPMOP-8) scheduled to be held in Mexico in December 2016.

Status of GM crops in India

Bt cotton is the only approved GM crop in India.

More than 20 crops are at various stages of field trials and safety assessment

More than 50 crops under research in both public and private sector.

Public Research – GM Crop Trials

Private Research – GM Crop Trials

Capacity Building on Biosafety

MoEFCC is actively engaged in Capacity building in biosafety using National and International resources

Several capacity building activities undertaken by

MoEFCC in association with other concerned Ministries like DBT, MoA, ICAR, Research Institutions, State Department of Agriculture, State Agricultural Universities etc.

MoEFCC is implementing UNEP/GEF supported

Phase-II Capacity Building Project on Biosafety since 2012.

Phase-II Biosafety Project: Key Points • Ministry of Environment, Forest and Climate

Change is the Nodal Ministry for Implementation of the Project

• The objective of the project is to strengthen biosafety management system in India

• Activities undertaken under four thrust areas: • Risk Assessment and Risk Management • Handling, Transport, Packaging and

Identification • Socio-economic considerations • Information dissemination and public

awareness

Thrust Areas

Risk Assessment

and Risk Management

Handling, Transport,

Packaging and Identification

Public Awareness

Socio-Economic Considerations

Workshops/ Trainings

Preparation of Outreach Materials

Development of Guidelines/ Manuals

Capacity Building

Stakeholder Involvement

Policy Makers Scientists & Researchers

Legal Experts & Economists

Enforcement Officials (Customs, Plant Quarantine Seed

Inspectors, Food Safety Inspectors, SBB)

Media/ farmers/ Students

Project Outcomes

Guidance on Environmental Risk Assessment have been adopted by the GEAC

Manuals and tools for trainers developed for monitoring, risk communication etc.

Baseline documents prepared on key topics relevant to the thrust areas

Training workshops organized for multiple stakeholders viz. members of regulatory committees, scientists, custom officials, state biodiversity boards, food safety inspectors, plant quarantine officials etc.

Way Forward

Activities to continue for dissemination of project outputs to stakeholders under the project.

Translation of outreach material into local languages for wider circulation.

Resource documents to be used for development of policies/guidelines in future.

Phase III project to be planned for continuing capacity building in biosafety

Thank You !!!