NATIONAL WEBSITES

Ministry of Environment, Forests and Climate Change (MoEF&CC)
The Ministry of Environment, Forests and Climate Change is the nodal agency for the planning, promotion, co-ordination and overseeing the implementation of environmental and forestry programs in India. Ministry of Environment, Forests and Climate Change has promulgated the “Rules for manufacture, use/import/ export & storage of hazardous micro organisms/ genetically engineered organisms or cells, 1989”, under the Environment Protection Act, 1986.

The Ministry is also the nodal agency for the implementation of the Convention on Biological Diversity (CBD) and Cartagena Protocol on Biosafety.

Department of Biotechnology
The Department of Biotechnology (DBT), under the Ministry of Science and Technology is the nodal department for biotechnology in Government of India. In more than 25 years of its existence, the department has promoted and accelerated the pace of research and development of biotechnology in the country. Through several R&D projects, demonstrations and creation of infrastructural facilities a clear visible impact of this field has been seen. The department has made significant achievements in the growth and application of biotechnology in the broad areas of agriculture, health care, animal sciences, environment, and industry. Along with MoEF, DBT is the implementing agency for biosafety regulations in the country.

Indian Biosafety Rules & Regulations by DBT
The website on Indian biosafety rules and regulations is to advice, facilitate and regulate modern biotechnology work at different stages to achieve the objectives of protecting environment including human and animal health from the unintended adverse effects of GMOs and products thereof. The objective of this website is to facilitate and disseminate the statutory requirements to be adhered by the researchers who are undertaking research work using modern biotechnology tools. The stepwise procedures to be adopted for development of transgenic crops, r-DNA therapeutics etc. as on date can be viewed or downloaded from the website for compliance by the users of rDNA technology.

Indian GMO Research Information System (IGMORIS)
Indian GMO Research Information System (IGMORIS) is a database on activities involving the use of GMOs and products thereof in India. The primary purpose of this website is to make available objective and realistic scientific information relating to GMOs and products thereof under research and commercial use to all stakeholders including scientists, regulators, industry and the public in general. It is also expected to promote collaborations and avoid duplication of work.

Department of Agriculture and Cooperation (DAC)
The Department of Agriculture and Cooperation (DAC), is one of the three departments under the Ministry of Agriculture. The department is organized into 24 divisions, 20 subordinate offices including directorates as directorate of cotton development, directorate of sugarcane development etc and seven autonomous bodies. DAC is responsible for the formulation and implementation of National policies and programs aimed at achieving rapid agricultural growth through optimum utilization of the country’s land, water, soil and plant resources. The Department also participates in activities of international organizations, for fostering bilateral cooperation in agricultural and allied sectors and for promotion of export in agricultural commodities.

Indian Council of Agricultural Research
The Indian Council of Agricultural Research (ICAR) is an autonomous organization under the Department of Agricultural Research and Education (DARE), Ministry of Agriculture, Government of India. The Council is the apex body for coordinating, guiding and managing research and education in agriculture including horticulture, fisheries and animal sciences in the entire country. With 97 ICAR institutes and 47 agricultural universities spread across the country this is one of the largest national agricultural systems in the world.

Food Safety and Standard Authority of India
The Food Safety and Standards Authority of India (FSSAI) has been established under Food Safety and Standards Act, 2006 which consolidates various acts & orders that have hitherto handled food related issues in various Ministries and Departments in India. FSSAI is a single reference point for all matters relating to food safety and standards, by moving from multi- level, multi- departmental control to a single line of command.

Capacity Building on Biosafety
This website has information on the activities taken under the GEF-World Bank phase I project on capacity building in biosafety (2004-2007) implemented by the Ministry of Environment and Forests.

INTERNATIONAL WEBSITES

Cartagena Protocol on Biosafety (CPB)
 This is the main site for information about the CPB, including the background and full text of the agreement, articles, updated list of signatures and ratifications, meetings, documents, the Biosafety Clearing House and various databases such as capacity-building activities etc. The governing body of the Protocol is the Conference of the Parties (COP) to the Convention serving as the Meeting of the Parties (MOP) to the Protocol. The main function of this body is to review the implementation of the Protocol and make decisions or provide necessary guidance to promote its effective operation.
 
Biosafety Clearing-House
As per the article 20 of the Cartagena Protocol on Biosafety, the Biosafety Clearing House (BCH) has been established which serves as an information exchange mechanism to assist Parties to implement its provisions and to facilitate sharing of information and experiences with Living Modified Organisms (LMOs). It provides a “one – stop shop” where users can readily access or contribute relevant biosafety related information with an objective to assist governments to make informed decisions regarding the importation or release of LMOs. The BCH also facilitates scientific and technical cooperation between parties and stakeholders by allowing interested stakeholders to access or contribute information on existing biosafety capacity building activities, thus facilitating coordination and synergy between various initiatives. For industry and other stakeholders the BCH allows easy access to information vital to their activities including details of the national contacts, relevant laws and regulations governing LMO activities and the decisions and declarations made by Parties, especially regard to transboundary movements.

The central portal of BCH is at http://bch.biodiv.org. All the Parties to the Protocol are expected to participate in BCH either by providing information through the central portal or setting up their own websites linked to the central portal.  

OECD - BioTrack
BioTrack Online, the web site of OECD's Programme on the Harmonization of Regulatory Oversight in Biotechnology, was created in 1995. This site focuses on information related to the regulatory oversight of products of biotechnology. BioTrack Online aims, not only to help member country governments and industries with biotechnology product notifications/assessments, but also to make the information, developed by the Working Group on Harmonization of Regulatory Oversight in Biotechnology, accessible to all who need it, including non-OECD countries that might find it useful.
 
The central portal of BCH is at http://bch.biodiv.org.  All the Parties to the Protocol are expected to participate in BCH either by providing information through the central portal or setting up their own websites linked to the central portal.

Food and Agriculture Organization (FAO)
The Food and Agriculture Organization (FAO) of the United Nations has the mandate to raise levels of nutrition, improve agricultural productivity, better the lives of rural populations and contribute to the growth of the world economy. As a knowledge organization, FAO creates and shares critical information about food, agriculture and natural resources in the form of global public goods. But this is not a one-way flow. FAO plays a connector role, through identifying and working with different partners with established expertise, and facilitating a dialogue between those who have the knowledge and those who need it.


During the period 2002-10, FAO had undertaken an intense activity of biosafety capacity development, centered largely on enhancing the capacities of regulators and others involved in the implementation of biosafety frameworks, along with other components. A Biosafety Resource Book was prepared to serve as reference material for biosafety regulators, policy-makers and members of national biosafety committees that can be readily consulted beyond the training events, when the need arises.  

World Health Organization (WHO) – Biotech Foods
WHO has been addressing a wide range of issues in the field of biotechnology and human health, including safety evaluation of vaccines produced using biotechnology, human cloning, and gene therapy. This site briefly describes the activities of WHO in regard to biotechnology and food safety.
 
Codex Alimentarius Commission (CAC)
The Codex Alimentarius Commission (CAC), established jointly by FAO and WHO in 1963 develops harmonized international food standards, guidelines and codes of practice to protect the health of the consumers and ensure fair trade practices in the food trade. The Codex standards are based on the best available science assisted by independent international risk assessment bodies or ad-hoc consultations organized by FAO/WHO. The Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology that was convened in 2000 with the objective to develop standards and guidelines for GM foods summarized their work in two documents namely Principles for the risk analysis of foods derived from modern biotechnology and Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants.

REGULATORY WEBSITES IN OTHER COUNTRIES

ARGENTINA

National Advisory Commission on Agricultural Biosafety (CONABia)
 CONABia under the Ministry of Agriculture is responsible for harmonizing policies relating to biosafety. It is a multidisciplinary advisory group that overlooks the regulation of products of agricultural biotechnology and also evaluates the scientific and technical issues of environmental release of GM crops.
 
Association of Southeast Asian Nations (ASEAN)    
The Association of Southeast Asian Nations (ASEAN) countries forms of the world’s largest mega biodiversity centre. The ASEAN overlooks the biosafety policy formulation and implementation across member countries i.e. Cambodia, Myanmar, Thailand, Singapore, Philippines, Vietnam, Bruni Darussalam etc.
 
AUSTRALIA
The regulatory framework of Australia involves the Office of the Gene Technology Regulator, Food Standards Australia New Zealand and Australian Government Department of Agriculture, Fisheries and Forestry.
 
Office of the Gene Technology Regulator (OGTR)
The OGTR is the competent authority for implementing the legislation of the Gene Technology Act, 2000 that regulates all dealings with live and viable GMOs in Australia, including research, manufacture, import, production, propagation, transport and disposal of GMOs. The OGTR maintains a record of GMO and Gm product dealings on its website. The complete list of all GMO dealings approved by the Regulator and of all GM product approvals notified to the Regulator by other product regulators are available at OGTR.
 
Australian Government Department of Agriculture, Fisheries and Forestry (DAFF)
The Australian Quarantine and Inspection Service (AQIS), that forms part of DAFF functions in regulation of imports for quarantine purposes, inspection and certification of exported primary products consistent with the importing country’s quarantine requirements and Australian export legislation and imported food inspection to meet Australian food standards.

Food Standard Australian and New Zealand (FSANZ)
FSANZ is a bi-national Government agency that carries out safety assessments on a case-by-case basis, which means each new genetic modification is assessed individually for its potential impact on the safety of food developed and food standards that cover the food industry in Australia and New Zealand. It also administers the Australia New Zealand Food Standards Code, which regulates the use of ingredients, processing aids, colorings etc and covers composition of some foods e.g. dairy, meat and beverages as well as standards developed by new technologies such as genetically modified foods. FSANZ is responsible for labeling both packaged and unpackaged food, including specific mandatory warnings or advisory label.

BRAZIL
National Technical Commission on Biosafety (CTNBio)
CTNBio under the Ministry of the Science and Technology has regulatory duties related to biotechnology and biosafety. CTNBio is responsible for the safe implementation of the research and development in biotechnology and for submission of applications to the National Committee. It shall monitor and notify the National Committee and competent authorities in case of any harm posed to people or to the environment.
 
CANADA
In Canada, the Canadian Food Inspection Agency and Health Canada share responsibility for regulating novel agricultural products. The federal government regulations ensure the practical benefits of biotech products in a way that protects health, safety and the environment.
 
Canadian Food Inspection Agency (CFIA)
CFIA is responsible for assessing the safety of plants with novel traits, animal feeds and animal feed ingredients, fertilizers and veterinary biologics. CFIA along with Health Canada shares responsibility for regulating products derived from biotechnology.

Health Canada
Health Canada is responsible for assessing the human health safety of products derived through biotechnology including foods, drugs, cosmetics, medical devices and pest control products.

Environment Canada
Environment Canada is a science-based department. It establishes and monitors biotech products other than agriculture that are regulated in Canada. It provides the science and technology information needed for making informed decisions about the environment.

EUROPEAN UNION (EU)
European Food Safety Authority (EFSA)

The European Food Safety Authority (EFSA) of European Union (EU) overlooks the risk assessment regarding food and feed safety. In close collaboration with national authorities and in open consultation with its stakeholders, EFSA provides independent scientific advice and clear communication on existing and emerging risks.

The Directive 2001/18/EC of the EU contains part B relevant to release for research and development which is used for conduct of experimental filed trials on GM crops and part C relevant to release for placing a GM product on the market require consent.

USA
Three federal agencies of USA the United States Department of Agriculture, Environmental Protection Agency and Food and Drug Administration share primary responsibility for regulating biotechnology in the United States.
 
United States Department of Agriculture (USDA)

The USDA reviews biotechnology derived applications, which contain or are produced using potential plant pests. It also regulates veterinary biologics, which are products derived from living sources, such as blood products and vaccines, and is largely responsible for assuring the safety of meat and poultry products.

Environmental Protection Agency (EPA)
The Environmental Protection Agency regulates biotechnology-derived plant or microbial pesticides or new chemical substances.

U.S. Food and Drug Administration (FDA)
The FDA regulates foods and feed derived from new plant varieties (GMOs) as well as conventional products. The biotechnology site carries extensive documentation on regulations, labeling, consumer information, and products approved for commercial sale.

UGANADA
Uganda National Council for Science and Technology (UNCST)
Uganda National Council for Science and Technology (UNCST), under the Ministry of Finance Planning and Economic Development coordinates the biosafety regulatory system in Uganda. The Council is mandated to facilitate and coordinate the development and implementation of policies and strategies for integrating Science and Technology (S&T) into the national development process. The council established the National Biotechnology Committee (NBC) with the mandate to provide technical advice on biosafety issues, including the assessment of individual applications for activities with GE organisms.
 
GENERAL INFORMATION

AgBioWorld
This site provides information about technological advances in agriculture to the developing world; particularly to teachers, scientists, journalists, and the general public on the relevance of agricultural biotechnology to sustainable development; maintains the declaration of “Scientists In Support Of Agricultural Biotechnology,” and offers a discussion list serve.

African Biosafety Network of Expertise (ABNE)
The African Biosafety Network of Expertise (ABNE) is an Africa-based, Africa-led initiative established by the AU/NEPAD’s Office of Science and Technology. ABNE is a continent-wide service network that was officially approved in 2008 by the African Ministerial Council on Science and Technology (AMCOST) to promote advancement of science and technology for agricultural development in Africa. ABNE biosafety services aim to empower African regulators with science-based information, targeting the members of National Biosafety Committees (NBCs), Institutional Biosafety Committees (IBCs), and Plant Quarantine Officers (PQs) so that they can make informed decisions on biotechnology products.

Centre for Environmental Risk Assessment (CERA)
The database by Centre for Environmental Risk Assessment (CERA) on safety information (formerly hosted by AGBIOS) is an excellent source of information on safety assessment studies reviewed by regulatory authorities for approval of genetically engineered plants. The database includes not only plants produced using rDNA technologies, but also plants with novel traits that may have been produced using more traditional methods, such as accelerated mutagenesis or plant breeding. These latter plants are only regulated in Canada.

GMO Compass
This database contains information about every genetically modified plant that has been approved or is awaiting approval in the EU. Information on the food and feed produced from the respective GM plant is also available.

International Life Sciences Institute (ILSI)
ILSI is a nonprofit, worldwide scientific research foundation seeking to improve the well being of the general public through the pursuit of sound and balanced science. It works towards understanding of scientific issues relating to nutrition, food safety, toxicology, risk assessment, and the environment. This site lists ILSI publications pertaining to biotechnology.

International Centre for Genetic Engineering and Biotechnology (ICGEB)
The role of the International Centre for Genetic Engineering and Biotechnology (ICGEB) is to promote the safe use of biotechnology world-wide, with special regards to the need of the developing world. It has played, since its inception, an important role on issues related to biosafety and the sustainable use of biotechnology.

The Biosafety Unit of the ICGEB is dedicated to biosafety and risk assessment for the environmental release of genetically modified organisms. It offers information on biosafety concerns, upcoming meetings and training courses, and a regularly updated index of selected scientific articles published on biosafety and risk assessment from 1990 onward. This site also carries an outstanding collection of links to databases on GMO releases, scientific bibliographies, decision support systems, patents, and numerous other topics.

International Service for the Acquisition of Agri-biotech Applications (ISAAA)
The International Service for the Acquisition of Agri-biotech Applications. ISAAA’s objectives are the transfer and delivery of appropriate biotechnology applications to developing countries and the building of partnerships between institutions in the South and the private sector in the North, and by strengthening South-South collaboration.

The primary site describes ISAAA’s activities and initiatives in biosafety, food safety, intellectual property, and technology transfer. The Global Knowledge Center on Crop Biotechnology section (http://www.isaaa.org/activities/ knowledge_center.htm) is organized into several main areas. Global Network provides a status of biotechnology in the developing countries of Asia, South America, and Africa. Crop Biotech Update is a weekly summary of world developments in agricultural biotechnology for developing countries. Separate pages cover GM products and biotechnology issues.