Below are links to biosafety related websites along with a brief description of the information that is available on each site.
The Bangladesh National Parliament passed the Food Safety Act, 2013 in order to make provisions for the establishment of an efficient, effective, scientifically based Authority and for regulating, through coordination, the activities relating to food production, import, processing, stockpiling, supplying, marketing and sales as well as to ensure the people’s right toward access to safe food through appropriate application of scientific processes and state of the art technology. The Bangladesh Food Safety Authority was established in 2015 with a commitment to make a united start with its full strength and unstinting efforts. The Authority whole-heartedly welcomes the all out support of all food control agencies, food business operators and people of the country towards the landmark goal of establishing a Modern and Technological Food Safety System in Bangladesh to contribute to the government’s Vision 2021.
The Department of Environment‘s mission is to help secure a clean and healthy environment for the benefit of present and future generations: through the fair and consistent application of environmental rules and regulations; through guiding, training, and promoting awareness of environmental issues; and through sustainable action on critical environmental problems that demonstrate practical solutions, and that galvanize public support and involvement.
National Institute of Biotechnology (NIB) is a governmental institute in Bangladesh under the Ministry of Science and Technology. It was established in 1999 by the government as part of an ADP project to intensify the biotechnological research in the country. The main objective of the institute is to coordinate the biotechnological researches carried out throughout the country as well as conducting its own research programs in different areas of biotechnology. The institute is also responsible to create skilled manpower for biotechnology and genetic engineering.
The Ministry of Environment, Forest and Climate Change (MoEF&CC) is the nodal agency for the planning, promotion, co-ordination and overseeing the implementation of environmental and forestry programs in India. Ministry of Environment, Forest 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.
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&CC, DBT is the implementing agency for biosafety regulations in the country.
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.
Other Government Websites
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.
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.
Food Standard Australian and New Zealand (FSANZ)
Food Standard Australian and New Zealand (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.
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.
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.
European Food Safety Authority (EFSA), European Union
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.
For the protection of plant health, the Biotechnology Regulatory Services (BRS) implements the Animal and Plant Health Inspection Service (APHIS) regulations for certain GE organism that may pose a risk to plant health. APHIS coordinates these responsibilities along with the other designated federal agencies as part of the Federal Coordinated Framework for the Regulation of Biotechnology.
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.
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.
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.
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.
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.
The purpose of the NIH Guidelines is to specify the practices for constructing and handling: (i) recombinant nucleic acid molecules, (ii) synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, and (iii) cells, organisms, and viruses containing such molecules. Any nucleic acid molecule experiment, which according to the NIH Guidelines requires approval by NIH, must be submitted to NIH or to another Federal agency that has jurisdiction for review and approval. Once approvals, or other applicable clearances, have been obtained from a Federal agency other than NIH (whether the experiment is referred to that agency by NIH or sent directly there by the submitter), the experiment may proceed without the necessity for NIH review or approval.
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.
The World Health Organization (WHO) has long recognized that safety and, in particular, biological safety are important international issues. WHO published the first edition of the Laboratory biosafety manual in 1983. The manual encouraged countries to accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of pathogenic microorganisms in laboratories within their geographical borders. Since 1983, many countries have used the expert guidance provided in the manual to develop such codes of practice. A second edition of the manual was published in 1993, and this third edition was published in 2004.
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.
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.
The GM Crop Database by the ILSI Research Foundation on safety information 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.
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.
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 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.