Cartagena Protocol on Biosafety

Last updated

Cartagena Protocol on Biosafety
Cartagena Protocol on Biosafety to the Convention on Biological Diversity
TypeEnvironmental
Drafted29 January 2000
Signed16 May 2000 [1]
Location Montreal, Quebec, Canada (originally scheduled for 1999 at Cartagena, Colombia)
Effective11 September 2003
Signatories103
Parties173 [2]
Depositary Secretary-General of the United Nations
LanguagesArabic, Chinese, English, French, Russian, and Spanish

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement on biosafety as a supplement to the Convention on Biological Diversity (CBD) effective since 2003. The Biosafety Protocol seeks to protect biological diversity from the potential risks posed by genetically modified organisms resulting from modern biotechnology.

Contents

The Biosafety Protocol makes clear that products from new technologies must be based on the precautionary principle and allow developing nations to balance public health against economic benefits. It will for example let countries ban imports of genetically modified organisms if they feel there is not enough scientific evidence that the product is safe and requires exporters to label shipments containing genetically altered commodities such as corn or cotton.

The required number of 50 instruments of ratification/accession/approval/acceptance by countries was reached in May 2003. In accordance with the provisions of its Article 37, the Protocol entered into force on 11 September 2003. As of July 2020, the Protocol had 173 parties, which includes 170 United Nations member states, the State of Palestine, Niue, and the European Union. [3] [4]

Background

The Cartagena Protocol on Biosafety, also known as the Biosafety Protocol, was adopted in January 2000, after a CBD Open-ended Ad Hoc Working Group on Biosafety had met six times between July 1996 and February 1999. The Working Group submitted a draft text of the Protocol, for consideration by Conference of the Parties at its first extraordinary meeting, which was convened for the express purpose of adopting a protocol on biosafety to the CBD. After a few delays, the Cartagena Protocol was eventually adopted on 29 January 2000 [5] The Biosafety Protocol seeks to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology. [6]

Objective

In accordance with the precautionary approach, contained in Principle 15 of the Rio Declaration on Environment and Development, 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 'living modified organisms 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)

The protocol defines a 'living modified organism' as any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology, and 'living organism' means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids. [7] 'Modern biotechnology' is defined in the Protocol to mean the application of in vitro nucleic acid techniques, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and are not techniques used in traditional breeding and selection. [7] 'Living modified organism (LMO) Products' are defined as processed material that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology. Common LMOs include agricultural crops that have been genetically modified for greater productivity or for resistance to pests or diseases. Examples of modified crops include tomatoes, cassava, corn, cotton and soybeans. [8] 'Living modified organism intended for direct use as food or feed, or for processing (LMO-FFP)' are agricultural commodities from GM crops. [7] Overall the term 'living modified organisms' is equivalent to genetically modified organism – the Protocol did not make any distinction between these terms and did not use the term 'genetically modified organism.' [9]

Precautionary approach

One of the outcomes of the United Nations Conference on Environment and Development (also known as the Earth Summit) held in Rio de Janeiro, Brazil, in June 1992, was the adoption of the Rio Declaration on Environment and Development, which contains 27 principles to underpin sustainable development. Commonly known as the precautionary principle, Principle 15 states that "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation."

Elements of the precautionary approach are reflected in a number of the provisions of the Protocol, such as:

Application

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).

Parties and non-parties

The governing body of the Protocol is called the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol (also the COP-MOP). The main function of this body is to review the implementation of the Protocol and make decisions necessary to promote its effective operation. Decisions under the Protocol can only be taken by Parties to the Protocol. Parties to the Convention that are not Parties to the Protocol may only participate as observers in the proceedings of meetings of the COP-MOP.

The Protocol addresses the obligations of Parties in relation to the transboundary movements of LMOs to and from non-Parties to the Protocol. The transboundary movements between Parties and non-Parties must be carried out in a manner that is consistent with the objective of the Protocol. Parties are required to encourage non-Parties to adhere to the Protocol and to contribute information to the Biosafety Clearing-House.

Relationship with the WTO

A number of agreements under the World Trade Organization (WTO), such as the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement), and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), contain provisions that are relevant to the Protocol. This Protocol states in its preamble that parties:

Main features

Overview of features

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 procedure, and 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. Furthermore, the shipment of LMOs subject to transboundary movement must be accompanied by appropriate documentation specifying, among other things, identity of LMOs and contact point for further information. These procedures and requirements are designed to provide importing Parties with the necessary information needed for making informed decisions about whether or not to accept LMO imports and for handling them in a safe manner.

The Party of import makes its decisions in accordance with scientifically sound risk assessments. The Protocol sets out principles and methodologies on how to conduct a risk assessment. In case of insufficient relevant scientific information and knowledge, the Party of import may use precaution in making their decisions on import. Parties may also take into account, consistent with their international obligations, socio-economic considerations in reaching decisions on import of LMOs.

Parties must also adopt measures for managing any risks identified by the risk assessment, and they must take necessary steps in the event of accidental release of LMOs.

To facilitate its implementation, the Protocol establishes a Biosafety Clearing-House for Parties to exchange information, and contains a number of important provisions, including capacity-building, a financial mechanism, compliance procedures, and requirements for public awareness and participation.

Procedures for moving LMOs across borders

Advance Informed Agreement

The "Advance Informed Agreement" (AIA) procedure applies to the first intentional transboundary movement of LMOs for intentional introduction into the environment of the Party of import. It includes four components: notification by the Party of export or the exporter, acknowledgment of receipt of notification by the Party of import, the decision procedure, and opportunity for review of decisions. The purpose of this procedure is to ensure that importing countries have both the opportunity and the capacity to assess risks that may be associated with the LMO before agreeing to its import. The Party of import must indicate the reasons on which its decisions are based (unless consent is unconditional). A Party of import may, at any time, in light of new scientific information, review and change a decision. A Party of export or a notifier may also request the Party of import to review its decisions.

However, the Protocol's AIA procedure does not apply to certain categories of LMOs:

While the Protocol's AIA procedure does not apply to certain categories of LMOs, Parties have the right to regulate the importation on the basis of domestic legislation. There are also allowances in the Protocol to declare certain LMOs exempt from application of the AIA procedure.

LMOs intended for food or feed, or for processing

LMOs intended for direct use as food or feed, or processing (LMOs-FFP) represent a large category of agricultural commodities. The Protocol, instead of using the AIA procedure, establishes a more simplified procedure for the transboundary movement of LMOs-FFP. Under this procedure, A Party must inform other Parties through the Biosafety Clearing-House, within 15 days, of its decision regarding domestic use of LMOs that may be subject to transboundary movement.

Decisions by the Party of import on whether or not to accept the import of LMOs-FFP are taken under its domestic regulatory framework that is consistent with the objective of the Protocol. A developing country Party or a Party with an economy in transition may, in the absence of a domestic regulatory framework, declare through the Biosafety Clearing-House that its decisions on the first import of LMOs-FFP will be taken in accordance with risk assessment as set out in the Protocol and time frame for decision-making.

Handling, transport, packaging and identification

The Protocol provides for practical requirements that are deemed to contribute to the safe movement of LMOs. Parties are required to take measures for the safe handling, packaging and transportation of LMOs that are subject to transboundary movement. The Protocol specifies requirements on identification by setting out what information must be provided in documentation that should accompany transboundary shipments of LMOs. It also leaves room for possible future development of standards for handling, packaging, transport and identification of LMOs by the meeting of the Parties to the Protocol.

Each Party is required to take measures ensuring that LMOs subject to intentional transboundary movement are accompanied by documentation identifying the LMOs and providing contact details of persons responsible for such movement. The details of these requirements vary according to the intended use of the LMOs, and, in the case of LMOs for food, feed or for processing, they should be further addressed by the governing body of the Protocol. (Article 18 of the Protocol, SCBD 2000).

The first meeting of the Parties adopted decisions outlining identification requirements for different categories of LMOs (Decision BS-I/6, SCBD 2004). However, the second meeting of the Parties failed to reach agreement on the detailed requirements to identify LMOs intended for direct use as food, feed or for processing and will need to reconsider this issue at its third meeting in March 2006.

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; and 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 (Decision BS-I/3, SCBD 2004).

See also

Related Research Articles

<span class="mw-page-title-main">Convention on Biological Diversity</span> International treaty on biological diversity

The Convention on Biological Diversity (CBD), known informally as the Biodiversity Convention, is a multilateral treaty. The Convention has three main goals: the conservation of biological diversity ; the sustainable use of its components; and the fair and equitable sharing of benefits arising from genetic resources. Its objective is to develop national strategies for the conservation and sustainable use of biological diversity, and it is often seen as the key document regarding sustainable development.

<span class="mw-page-title-main">Genetically modified organism</span> Organisms whose genetic material has been altered using genetic engineering methods

A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques. The exact definition of a genetically modified organism and what constitutes genetic engineering varies, with the most common being an organism altered in a way that "does not occur naturally by mating and/or natural recombination". A wide variety of organisms have been genetically modified (GM), including animals, plants, and microorganisms.

<span class="mw-page-title-main">Genetic engineering</span> Manipulation of an organisms genome

Genetic engineering, also called genetic modification or genetic manipulation, is the modification and manipulation of an organism's genes using technology. It is a set of technologies used to change the genetic makeup of cells, including the transfer of genes within and across species boundaries to produce improved or novel organisms. New DNA is obtained by either isolating and copying the genetic material of interest using recombinant DNA methods or by artificially synthesising the DNA. A construct is usually created and used to insert this DNA into the host organism. The first recombinant DNA molecule was made by Paul Berg in 1972 by combining DNA from the monkey virus SV40 with the lambda virus. As well as inserting genes, the process can be used to remove, or "knock out", genes. The new DNA can be inserted randomly, or targeted to a specific part of the genome.

<span class="mw-page-title-main">Biosafety</span> Prevention of large-scale loss of biological integrity

Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include the conduction of regular reviews of biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety is used to protect from harmful incidents. Many laboratories handling biohazards employ an ongoing risk management assessment and enforcement process for biosafety. Failures to follow such protocols can lead to increased risk of exposure to biohazards or pathogens. Human error and poor technique contribute to unnecessary exposure and compromise the best safeguards set into place for protection.

Biosecurity refers to measures aimed at preventing the introduction and/or spread of harmful organisms intentionally or unintentionally outside their native range and/or within new environments. In agriculture, these measures are aimed at protecting food crops and livestock from pests, invasive species, and other organisms not conducive to the welfare of the human population. The term includes biological threats to people, including those from pandemic diseases and bioterrorism. The definition has sometimes been broadened to embrace other concepts, and it is used for different purposes in different contexts.

The precautionary principle is a broad epistemological, philosophical and legal approach to innovations with potential for causing harm when extensive scientific knowledge on the matter is lacking. It emphasizes caution, pausing and review before leaping into new innovations that may prove disastrous. Critics argue that it is vague, self-cancelling, unscientific and an obstacle to progress.

This is an index of conservation topics. It is an alphabetical index of articles relating to conservation biology and conservation of the natural environment.

<span class="mw-page-title-main">Genetic use restriction technology</span> Methods for controlling the use of GMOs

Genetic use restriction technology (GURT), also known as terminator technology or suicide seeds, is the name given to proposed methods for restricting the use of genetically modified crops by activating some genes only in response to certain stimuli, especially to cause second generation seeds to be infertile. The development and application of GURTs is primarily an attempt by private sector agricultural breeders to increase the extent of protection on their innovations. The technology was originally developed under a cooperative research and development agreement between the Agricultural Research Service of the United States Department of Agriculture and Delta & Pine Land Company in the 1990s and is not yet commercially available.

The Biosafety Clearing-House is an international mechanism that exchanges information about the movement of genetically modified organisms, established under the Cartagena Protocol on Biosafety. It assists Parties to implement the protocol’s provisions and to facilitate sharing of information on, and experience with, living modified organisms. It further assists Parties and other stakeholders to make informed decisions regarding the importation or release of GMOs.

Since the advent of genetic engineering in the 1970s, concerns have been raised about the dangers of the technology. Laws, regulations, and treaties were created in the years following to contain genetically modified organisms and prevent their escape. Nevertheless, there are several examples of failure to keep GM crops separate from conventional ones.

The traceability of genetically modified organisms (GMOs) describes a system that ensures the forwarding of the identity of a GMO from its production to its final buyer. Traceability is an essential prerequisite for the co-existence of GM and non-GM foods, and for the freedom of choice for consumers.

The Wingspread Conference on the Precautionary Principle was a three-day academic conference where the precautionary principle was defined. The January 1998 meeting took place at Wingspread, headquarters of the Johnson Foundation in Racine, Wisconsin, and involved 35 scientists, lawyers, policy makers and environmentalists from the United States, Canada and Europe.

<span class="mw-page-title-main">Regulation of genetic engineering</span> Overview of the regulation of genetic engineering

The regulation of genetic engineering varies widely by country. Countries such as the United States, Canada, Lebanon and Egypt use substantial equivalence as the starting point when assessing safety, while many countries such as those in the European Union, Brazil and China authorize GMO cultivation on a case-by-case basis. Many countries allow the import of GM food with authorization, but either do not allow its cultivation or have provisions for cultivation, but no GM products are yet produced. Most countries that do not allow for GMO cultivation do permit research. Most (85%) of the world's GMO crops are grown in the Americas. One of the key issues concerning regulators is whether GM products should be labeled. Labeling of GMO products in the marketplace is required in 64 countries. Labeling can be mandatory up to a threshold GM content level or voluntary. A study investigating voluntary labeling in South Africa found that 31% of products labeled as GMO-free had a GM content above 1.0%. In Canada and the USA labeling of GM food is voluntary, while in Europe all food or feed which contains greater than 0.9% of approved GMOs must be labelled.

<span class="mw-page-title-main">Nagoya Protocol</span> Global treaty on biological diversity

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity, also known as the Nagoya Protocol on Access and Benefit Sharing (ABS) is a 2010 supplementary agreement to the 1992 Convention on Biological Diversity (CBD). Its aim is the implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources, thereby contributing to the conservation and sustainable use of biodiversity. It sets out obligations for its contracting parties to take measures in relation to access to genetic resources, benefit-sharing and compliance.

This is a list of notable events relating to the environment in 2003. They relate to environmental law, conservation, environmentalism and environmental issues.

The Biotechnology Regulatory Authority of India (BRAI) is a proposed regulatory body in India for uses of biotechnology products including genetically modified organisms (GMOs). The institute was first suggested under the Biotechnology Regulatory Authority of India (BRAI) draft bill prepared by the Department of Biotechnology in 2008. Since then, it has undergone several revisions.

<span class="mw-page-title-main">Genetically modified tree</span> Tree whose DNA has been modified using genetic engineering techniques

A genetically modified tree is a tree whose DNA has been modified using genetic engineering techniques. In most cases the aim is to introduce a novel trait to the plant which does not occur naturally within the species. Examples include resistance to certain pests, diseases, environmental conditions, and herbicide tolerance, or the alteration of lignin levels in order to reduce pulping costs.

India and China are the two largest producers of genetically modified products in Asia. India currently only grows GM cotton, while China produces GM varieties of cotton, poplar, petunia, tomato, papaya and sweet pepper. Cost of enforcement of regulations in India are generally higher, possibly due to the greater influence farmers and small seed firms have on policy makers, while the enforcement of regulations was more effective in China. Other Asian countries that grew GM crops in 2011 were Pakistan, the Philippines and Myanmar. GM crops were approved for commercialisation in Bangladesh in 2013 and in Vietnam and Indonesia in 2014.

The hazards of synthetic biology include biosafety hazards to workers and the public, biosecurity hazards stemming from deliberate engineering of organisms to cause harm, and hazards to the environment. The biosafety hazards are similar to those for existing fields of biotechnology, mainly exposure to pathogens and toxic chemicals; however, novel synthetic organisms may have novel risks. For biosecurity, there is concern that synthetic or redesigned organisms could theoretically be used for bioterrorism. Potential biosecurity risks include recreating known pathogens from scratch, engineering existing pathogens to be more dangerous, and engineering microbes to produce harmful biochemicals. Lastly, environmental hazards include adverse effects on biodiversity and ecosystem services, including potential changes to land use resulting from agricultural use of synthetic organisms.

References

  1. First signed by Kenya
  2. "UNTC". Archived from the original on 5 March 2014. Retrieved 4 March 2014..
  3. "United Nations Treaty Collection". United Nations. Archived from the original on 5 March 2014. Retrieved 24 July 2020.
  4. Unit, Biosafety (13 November 2019). "The Cartagena Protocol on Biosafety". The Biosafety Clearing-House (BCH). Retrieved 2 December 2019.
  5. "About the Protocol". Convention on Biological Diversity. Retrieved 17 September 2020.
  6. "Cartagena Protocol on Biosafety to the Convention on Biological Diversity" (PDF). cbd.int. Secretariat of the Convention on Biological Diversity. 2000. Retrieved 15 July 2020.
  7. 1 2 3 "Glossary".
  8. "Frequently Asked Questions (FAQs) on the Cartagena Protocol". Convention on Biological Diversity. United Nations Environment Programme. 29 February 2012. Retrieved 10 December 2017.
  9. "WHO 20 Questions on biotechnology".