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117-588: 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 . The Biosafety Protocol makes clear that products from new technologies must be based on

234-705: 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). Biosafety The international Cartagena Protocol on Biosafety deals primarily with

351-473: A principle of law is a source of law. This means that it is compulsory, so a court can quash or confirm a decision through the application of the precautionary principle. In this sense, the precautionary principle is not a simple idea or a desideratum but a source of law. This is the legal status of the precautionary principle in the European Union. On the other hand, an 'approach' usually does not have

468-453: A test pilot ). In the case of technological innovation, containment of impact tends to be more difficult if that technology can self-replicate. Bill Joy emphasised the dangers of replicating genetic technology, nanotechnology, and robotic technology in his article in Wired , " Why the future doesn't need us ", though he does not specifically cite the precautionary principle. The application of

585-592: A "general principle of EU law". In Case T-74/00 Artegodan , the General Court (then Court of First Instance) appeared willing to extrapolate from the limited provision for the precautionary principle in environmental policy in article 191(2) TFEU to a general principle of EU law. In France, the Charter for the Environment contains a formulation of the precautionary principle (article 5): When

702-502: A "quasi- option effect" which should induce a " risk -neutral" society to favour current decisions that allow for more flexibility in the future. Gollier et al. conclude that "more scientific uncertainty as to the distribution of a future risk – that is, a larger variability of beliefs – should induce society to take stronger prevention measures today." The principle was also derived from religious beliefs that particular areas of science and technology should be restricted as they "belong to

819-606: 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 The Biosafety Protocol seeks to protect biological diversity from

936-434: A balance between cost-effectiveness of safety measures and use evidence-based safety practices and recommendations, measure the outcomes and consistently reevaluate the potential benefits that biosafety represents for human health. Biosafety level designations are based on a composite of the design features, construction, containment facilities, equipment, practices and operational procedures required for working with agents from

1053-407: A certain decision (e.g. taking a particular course of action) and conclusive evidence is not yet available. For example, a government may decide to limit or restrict the widespread release of a medicine or new technology until it has been thoroughly tested. The principle acknowledges that while the progress of science and technology has often brought great benefit to humanity, it has also contributed to

1170-493: A committee or board of supervisors that is in charge of the institution's biosafety. They create and monitor the biosafety standards that must be met by labs in order to prevent the accidental release of potentially destructive biological material. (note that in the US, several groups are involved, and efforts are being made to improve processes for government run labs, but there is no unifying regulatory authority for all labs. Biosafety

1287-679: A lack of proper training or reinforcement of training and supervision on regular basis for lab personnel. Following these incidents, the CDC established an External Laboratory Safety Workgroup (ELSW), and suggestions have been made to reform effectiveness of the Federal Select Agent Program. The White House issued a report on national biosafety priorities in 2015, outlining next steps for a national biosafety and security program, and addressed biological safety needs for health research, national defense, and public safety. In 2016,

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1404-525: 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

1521-468: A lot of excitement in the pharmaceutical industry as they will be cheaper to produce, allow quicker production, as well as enhance the knowledge of virology and immunology . Biosafety, in medicine and health care settings, specifically refers to proper handling of organs or tissues from biological origin, or genetic therapy products, viruses with respect to the environment, to ensure the safety of health care workers, researchers, lab staff, patients, and

1638-588: A meeting of environmentalists in 1998, is another example of the strong version. Strong precaution can also be termed as a "no-regrets" principle, where costs are not considered in preventative action. Weak precaution holds that lack of scientific evidence does not preclude action if damage would otherwise be serious and irreversible. Humans practice weak precaution every day, and often incur costs, to avoid hazards that are far from certain: we do not walk in moderately dangerous areas at night, we exercise, we buy smoke detectors, we buckle our seatbelts. According to

1755-636: A potential infection hazard, according to the Environmental Protection Agency (EPA). Medical waste is required to be rendered non-infectious before it can be disposed of. There are several different methods to treat and dispose of biohazardous waste. In the United States, the primary methods for treatment and disposal of biohazard, medical and sharps waste may include: Different forms of biohazardous wasted required different treatments for their proper waste management. This

1872-567: A publication by the New Zealand Treasury Department: The weak version [of the Precautionary Principle] is the least restrictive and allows preventive measures to be taken in the face of uncertainty, but does not require them (e.g., Rio Declaration 1992; United Nations Framework Convention of Climate Change 1992). To satisfy the threshold of harm, there must be some evidence relating to both

1989-422: A reason for postponing cost-effective measures to prevent environmental degradation." As Garcia (1995) pointed out, "the wording, largely similar to that of the principle, is subtly different in that: it recognizes that there may be differences in local capabilities to apply the approach, and it calls for cost-effectiveness in applying the approach, e.g., taking economic and social costs into account." The "approach"

2106-462: A remote chance of irreparable damage to the ecology, then you shouldn't do it, no matter how great the possible advantages of the action may be. You are not allowed to balance costs against benefits when deciding what to do. As noted by Rupert and O'Riordan, the challenge in application of the principle is "in making it clear that absence of certainty, or there being insufficient evidence-based analysis, were not impediments to innovation, so long as there

2223-631: 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

2340-401: 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. In an engineering context,

2457-487: 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. '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

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2574-472: Is determined largely be each states regulations. The United States Government has made it clear that biosafety is to be taken very seriously. In 2014, incidents with anthrax and Ebola pathogens in CDC laboratories prompted the CDC director Tom Frieden to issue a moratorium for research with these types of select agents . An investigation concluded that there was a lack of adherence to safety protocols and "inadequate safeguards" in place. This indicated

2691-439: Is followed by three recommended sources for laboratory reference: While clearly the needs of biocontainment and biosafety measures vary across government, academic and private industry laboratories, biological agents pose similar risks independent of their locale. Laws relating to biosafety are not easily accessible and there are few federal regulations that are readily available for a potential trainee to reference outside of

2808-406: Is generally considered a softening of the "principle": As Recuerda has noted, the distinction between the precautionary principle and a precautionary approach is diffuse and, in some contexts, controversial. In the negotiations of international declarations, the United States has opposed the use of the term principle because this term has special connotations in legal language, due to the fact that

2925-735: Is generally considered to have arisen in English from a translation of the German term Vorsorgeprinzip in the 1970s in response to forest degradation and sea pollution , where German lawmakers adopted clean air act banning use of certain substances suspected in causing the environmental damage even though evidence of their impact was inconclusive at that time. The concept was introduced into environmental legislation along with other innovative (at that time) mechanisms such as "polluter pays", principle of pollution prevention and responsibility for survival of future ecosystems. The precautionary principle

3042-433: Is helping to enforce the knowledge and effectiveness of biosafety. With the potential future creation of man-made unicellular organisms, some are beginning to consider the effect that these organisms will have on biomass already present. Scientists estimate that within the next few decades, organism design will be sophisticated enough to accomplish tasks such as creating biofuels and lowering the levels of harmful substances in

3159-577: Is limited". Various interests being represented by various groups proposing the principle resulted in great variability of its formulation: one study identified 14 different formulations of the principle in treaties and non-treaty declarations. R.B. Stewart (2002) reduced the precautionary principle to four basic versions: Carolyn Raffensperger of the Wingspread convention placed the principle in opposition to approaches based on risk management and cost-benefit analysis . Dave Brower ( Friends of

3276-556: Is limited. Medical waste management was identified as an issue in the 1980s, with the Medical Waste Tracking Act of 1988 becoming the new standard in biohazard waste disposal . Although the Federal Government, EPA & DOT provide some oversight of regulated medical waste storage, transportation, and disposal the majority of biohazard medical waste is regulated at the state level. Each state

3393-506: Is made of assignment of liability for environmental harm. Strong versions justify or require precautionary measures and some also establish liability for environmental harm, which is effectively a strong form of "polluter pays". For example, the Earth Charter states: "When knowledge is limited apply a precautionary approach ... Place the burden of proof on those who argue that a proposed activity will not cause significant harm, and make

3510-582: Is much wider, and specifically where preliminary-objective-scientific-evaluation indicates that there are reasonable grounds for concern that potentially dangerous effects on the environment, human, animal or [and] plant health may be inconsistent with the high level of protection [for what] chosen for the Community." The January 2000 Cartagena Protocol on Biosafety says, in regard to controversies over GMOs : "Lack of scientific certainty due to insufficient relevant scientific information ... shall not prevent

3627-415: Is not the risk that must be avoided or amended, but a potential risk that must be prevented. Thus, in the case of regulation of scientific research, there is a third party beyond the scientist and the regulator: the consumer. In an analysis concerning application of the precautionary principle to nanotechnology , Chris Phoenix and Mike Treder posit that there are two forms of the principle, which they call

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3744-913: Is related to several fields: Chemical hazards typically found in laboratory settings include carcinogens , toxins , irritants , corrosives , and sensitizers . Biological hazards include viruses, bacteria, fungi, prions , and biologically derived toxins, which may be present in body fluids and tissue, cell culture specimens, and laboratory animals . Routes of exposure for chemical and biological hazards include inhalation , ingestion , skin contact, and eye contact. Physical hazards include ergonomic hazards , ionizing and non-ionizing radiation , and noise hazards . Additional safety hazards include burns and cuts from autoclaves , injuries from centrifuges , compressed gas leaks, cold burns from cryogens , electrical hazards , fires , injuries from machinery , and falls . A complete understanding of experimental risks associated with synthetic biology

3861-568: Is required whenever there is a possible risk to health, safety, or the environment, even if the supporting evidence is speculative and even if the economic costs of regulation are high. In 1982, the United Nations World Charter for Nature gave the first international recognition to the strong version of the principle, suggesting that when "potential adverse effects are not fully understood, the activities should not proceed". The widely publicised Wingspread Declaration, from

3978-469: Is responsible for regulation and management of their own biohazardous waste with each state varying in their regulatory process. Record keeping of biohazardous waste also varies between states. Medical healthcare centers, hospitals veterinary clinics, clinical laboratories and other facilities generate over one million tons of waste each year. Although the majority of this waste is as harmless as common household waste, as much as 15 percent of this waste poses

4095-453: The Centers for Disease Control and Prevention website much of the design, implementation and monitoring of protocols are left up to state and local authorities. The United States CFR states "An individual or entity required to register [as a user of biological agents] must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin" which

4212-528: The Lisbon Treaty states that: Union policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay. After

4329-615: The Occupational Safety and Health Act of 1970. but currently, there is no single federal regulating agency directly responsible for ensuring the safety of biohazardous handling, storage, identification, clean-up and disposal. In addition to the CDC, the Environmental Protection Agency has some of the most accessible information on ecological impacts of biohazards, how to handle spills, reporting guidelines and proper disposal of agents dangerous to

4446-663: The Wingspread Conference on the Precautionary Principle was convened by the Science and Environmental Health Network and concluded with the following formulation, described by Stewart Brand as "the clearest and most frequently cited": When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. In this context

4563-521: The codification (law) , or collection of laws specific to a specific to a jurisdiction that represent broad areas subject to federal regulation. Title 42 of the Code of Federal Regulations addresses laws concerning Public Health issues including biosafety which can be found under the citation 42 CFR 73 to 42 CFR 73.21 by accessing the US Code of Federal Regulations (CFR) website. Title 42 Section 73 of

4680-467: The laboratory director, who holds immediate responsibility for the laboratory, is tasked with ensuring the development and adoption of a biosafety management plan as well as a safety or operations manual. Secondly, the laboratory supervisor, who reports to the laboratory director, is responsible for organizing regular training sessions on laboratory safety. The third point, the personnel must be informed about any special hazards and be required to review

4797-480: 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

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4914-404: 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

5031-557: The "strict form" and the "active form". The former "requires inaction when action might pose a risk", while the latter means "choosing less risky alternatives when they are available, and [...] taking responsibility for potential risks." Thomas Alured Faunce has argued for stronger application of the precautionary principle by chemical and health technology regulators particularly in relation to Ti0 2 and ZnO nanoparticles in sunscreens , biocidal nanosilver in waterways and products whose manufacture, handling or recycling exposes humans to

5148-656: The 2009 Task Force on BioSafety. There was also a formation of a Blue Ribbon Study Panel on Biodefense , but this is more concerned with national defense programs and biosecurity. Ultimately states and local governments, as well as private industry labs, are left to make the final determinants for their own biosafety programs, which vary widely in scope and enforcement across the United States. Not all state programs address biosafety from all necessary perspectives, which should not just include personal safety, but also emphasize an full understanding among laboratory personnel of quality control and assurance, exposure potential impacts on

5265-699: The Association of Public Health Laboratories (APHL) had a presentation at their annual meeting focused on improving biosafety culture. This same year, The UPMC Center for Health Security issued a case study report including reviews of ten different nations' current biosafety regulations, including the United States. Their goal was to "provide a foundation for identifying national-level biosafety norms and enable initial assessment of biosafety priorities necessary for developing effective national biosafety regulation and oversight." Precautionary principle The precautionary principle (or precautionary approach )

5382-581: The CFR addresses specific aspects of biosafety including occupational safety and health , transportation of biohazardous materials and safety plans for laboratories using potential biohazards. While biocontainment , as defined in the Biosafety in Microbiological and Biomedical Laboratories and Primary Containment for Biohazards: Selection, Installation and Use of Biosafety Cabinets manuals available at

5499-497: The Earth ) concluded that "all technology should be assumed guilty until proven innocent". Freeman Dyson described the application of precautionary principle as "deliberately one-sided", for example when used as justification to destroy genetic engineering research plantations and threaten researchers in spite of scientific evidence demonstrating lack of harm: The Precautionary Principle says that if some course of action carries even

5616-420: The German concept for a British audience, which he translated into English as the precautionary principle. In economics, the Precautionary Principle has been analyzed in terms of "the effect on rational decision-making", of "the interaction of irreversibility " and " uncertainty ". Authors such as Epstein (1980) and Arrow and Fischer (1974) show that "irreversibility of possible future consequences" creates

5733-615: The Party of [I]mport, in order to avoid or minimize such potential adverse effects, from taking a decision, as appropriate, with regard to the import of the living modified organism in question." Pope Francis makes reference to the principle and the Rio Declaration in his 2015 encyclical letter , Laudato si' , noting that alongside its environmental significance, the precautionary principle "makes it possible to protect those who are most vulnerable and whose ability to defend their interests and to assemble incontrovertible evidence

5850-462: 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

5967-526: 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

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6084-606: The Protocol and time frame for decision-making. 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

6201-705: The Protocol and to contribute information to the Biosafety Clearing-House. 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

6318-527: 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

6435-498: 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

6552-492: 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 direct use as food or feed, or processing (LMOs-FFP) represent

6669-512: The Protocol. This Protocol states in its preamble that parties: 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

6786-506: The State's plans for occupational health and safety. With the exception of DoD lab personnel, CDC lab personnel, First responders, and DoT employees, enforcement of training is inconsistent, and while training is required to be done, specifics on the breadth and frequency of refresher training does not seem consistent from state to state; penalties may never be assessed without larger regulating bodies being aware of non-compliance, and enforcement

6903-477: The Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight recommended the formation of an agency to coordinate high safety risk level labs (3 and 4), and voluntary, non-punitive measures for incident reporting. However, it is unclear as to what changes may or may not have been implemented following their recommendations. The United States Code of Federal Regulations is

7020-401: The United States. Agencies involved in producing policies surrounding biosafety within a hospital, pharmacy or clinical research laboratory include: the CDC, FDA , USDA , DHHS , DoT, EPA and potentially other local organizations including public health departments. The federal government does set some standards and recommendations for States to meet their standards, most of which fall under

7137-532: The adoption of the European Commission's communication on the precautionary principle, the principle has come to inform much EU policy, including areas beyond environmental policy . As of 2006 it had been integrated into EU laws "in matters such as general product safety, the use of additives for use in animal nutrition, the incineration of waste, and the regulation of genetically modified organisms". Through its application in case law , it has become

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7254-410: The agricultural definition but many advocacy groups seek to expand it to include post-genetic threats: new molecules, artificial life forms, and even robots which may compete directly in the natural food chain. Biosafety in agriculture, chemistry, medicine, exobiology and beyond will likely require the application of the precautionary principle , and a new definition focused on the biological nature of

7371-457: The appellate court to stop the planting of Bt eggplant in test fields, saying the impacts of such an undertaking to the environment, native crops and human health are still unknown. The Court of Appeals granted the petition, citing the precautionary principle stating "when human activities may lead to threats of serious and irreversible damage to the environment that is scientifically plausible but uncertain, actions shall be taken to avoid or diminish

7488-519: The application of the principle... decisions should be guided by: (i) careful evaluation to avoid, wherever practicable, serious or irreversible damage to the environment; and (ii) an assessment of risk-weighted consequence of various options". The most significant points of Justice Preston's decision are the following findings: A petition filed 17 May 2013 by environmental group Greenpeace Southeast Asia and farmer-scientist coalition Masipag ( Magsasaka at Siyentipiko sa Pagpapaunlad ng Agrikultura ) asked

7605-495: The atmosphere. Scientist that favor the development of synthetic biology claim that the use of biosafety mechanisms such as suicide genes and nutrient dependencies will ensure the organisms cannot survive outside of the lab setting in which they were originally created. Organizations like the ETC Group argue that regulations should control the creation of organisms that could potentially harm existing life. They also argue that

7722-540: The case of the Ebola outbreak the impact that it had on businesses and travel required that private sectors, international banks together pledged more than $ 2 billion to combat the epidemic. The bureau of international Security and nonproliferation (ISN) is responsible for managing a broad range of U.S. nonproliferation policies, programs, agreements, and initiatives, and biological weapon is one their concerns Biosafety has its risks and benefits. All stakeholders must try to find

7839-562: 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). 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. 'Modern biotechnology'

7956-461: The creation of new threats and risks. It implies that there is a social responsibility to protect the public from exposure to such harm, when scientific investigation has found a plausible risk. These protections should be relaxed only if further scientific findings emerge that provide sound evidence that no harm will result. The principle has become an underlying rationale for a large and increasing number of international treaties and declarations in

8073-602: The decision of the Court of Appeals which stopped the field trials for the genetically modified eggplant. The court is the first in the world to adopt the precautionary principle regarding GMO products in its decision. The Supreme Court decision was later reversed following an appeal by researchers at the University of the Philippines Los Baños. Body Shop International , a UK-based cosmetics company, included

8190-420: The development of these organisms will simply shift the consumption of petroleum to the utilization of biomass in order to create energy. These organisms can harm existing life by affecting the prey/predator food chain, reproduction between species, as well as competition against other species (species at risk, or act as an invasive species). Synthetic vaccines are now being produced in the lab. These have caused

8307-399: The effects of your action are compatible with the permanence of genuine human life" or, stated conversely, "Do not compromise the conditions for an indefinite continuation of humanity on earth." To achieve this Jonas argued for the cultivation of a cautious attitude toward actions that may endanger the future of humanity or the biosphere that supported it. In 1988, Konrad von Moltke described

8424-434: The environment, and general public safety. Toby Ord puts into question whether the current international conventions regarding biotechnology research and development regulation, and self-regulation by biotechnology companies and the scientific community are adequate. State occupational safety plans are often focused on transportation, disposal, and risk assessment, allowing caveats for safety audits, but ultimately leaves

8541-565: The environment. Many of these agencies have their own manuals and guidance documents relating to training and certain aspects of biosafety directly tied to their agency's scope, including transportation, storage and handling of blood borne pathogens (OSHA, IATA ). The American Biological Safety Association (ABSA) has a list of such agencies and links to their websites, along with links to publications and guidance documents to assist in risk assessment, lab design and adherence to laboratory exposure control plans. Many of these agencies were members of

8658-402: The evidence that certain animals are sentient sufficient whenever "statistically significant evidence ... of the presence of at least one credible indicator of sentience in at least one species of that order" has been obtained. For practical reasons, Birch says, the evidence of sentience should concern the order , so that if one species meets the conditions of sentience, then all the species of

8775-431: The extreme, such a requirement could involve bans and prohibitions on entire classes of potentially threatening activities or substances (Cooney, 2005). Over time, there has been a gradual transformation of the precautionary principle from what appears in the Rio Declaration to a stronger form that arguably [by whom] acts as restraint on development in the absence of firm evidence that it will do no harm. No introduction to

8892-435: The fields of sustainable development, environmental protection, health, trade, and food safety, although at times it has attracted debate over how to accurately define it and apply it to complex scenarios with multiple risks. In some legal systems, as in law of the European Union , the application of the precautionary principle has been made a statutory requirement in some areas of law. The concept "precautionary principle"

9009-417: 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

9126-458: The general public. Laboratories are assigned a biosafety level numbered 1 through 4 based on their potential biohazard risk level. The employing authority, through the laboratory director, is responsible for ensuring that there is adequate surveillance of the health of laboratory personnel. The objective of such surveillance is to monitor for occupationally acquired diseases. The World Health Organization attributes human error and poor technique as

9243-557: 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. The Protocol established

9360-637: The handling of biohazardous materials and lack of reporting. Poor record keeping, improper disposal, and mishandling biohazardous materials result in increased risks of biochemical contamination for both the public and environment. Along with the precautions taken during the handling process of biohazardous materials, the World Health Organization recommends: Staff training should always include information on safe methods for highly hazardous procedures that are commonly encountered by all laboratory personnel, and which involve: First of all

9477-509: The likelihood of occurrence and the severity of consequences. Some, but not all, require consideration of the costs of precautionary measures. Weak formulations do not preclude weighing benefits against the costs. Factors other than scientific uncertainty, including economic considerations, may provide legitimate grounds for postponing action. Under weak formulations, the requirement to justify the need for action (the burden of proof) generally falls on those advocating precautionary action. No mention

9594-453: 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

9711-421: The occurrence of any damage, albeit unpredictable in the current state of scientific knowledge, may seriously and irreversibly harm the environment, public authorities shall, with due respect for the principle of precaution and the areas within their jurisdiction, ensure the implementation of procedures for risk assessment and the adoption of temporary measures commensurate with the risk involved in order to preclude

9828-691: The occurrence of such damage. On 18 July 2005, the City of San Francisco passed a precautionary principle purchasing ordinance, which requires the city to weigh the environmental and health costs of its $ 600 million in annual purchases – for everything from cleaning supplies to computers. Members of the Bay Area Working Group on the Precautionary Principle contributed to drafting the Ordinance. The most important Australian court case so far, due to its exceptionally detailed consideration of

9945-489: 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,

10062-589: The potential risks posed by living modified organisms resulting from modern biotechnology. 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

10179-415: The precautionary approach are reflected in a number of the provisions of the Protocol, such as: 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). The governing body of

10296-426: The precautionary principle consists of an epistemic and a decision rule. The former concerns the "evidential bar" that should be required for animal sentience. In other words, how much evidence of sentience is necessary before one decides to apply precautionary measures? According to Birch, only some evidence would be sufficient, which means that the evidential bar should be set at low levels. Birch proposes to consider

10413-473: The precautionary principle has been invoked in order to grant potentially sentient animals "basic legal protections". Birch's formulation of the animal sentience precautionary principle runs as follows: Where there are threats of serious, negative animal welfare outcomes, lack of full scientific certainty as to the sentience of the animals in question shall not be used as a reason for postponing cost-effective measures to prevent those outcomes. This version of

10530-453: The precautionary principle in their 2006 chemicals strategy. Fields typically concerned by the precautionary principle are the possibility of: The precautionary principle is often applied to biological fields because changes cannot be easily contained and have the potential of being global. The principle has less relevance to contained fields such as aeronautics , where the few people undergoing risk have given informed consent (e.g.,

10647-421: The precautionary principle manifests itself as the factor of safety , discussed in detail in the monograph of Elishakoff . It was apparently suggested, in civil engineering, by Belidor in 1729. Interrelation between safety factor and reliability is extensively studied by engineers and philosophers. The principle is often used by policy makers in situations where there is the possibility of harm from making

10764-422: The precautionary principle suitable for the problem of animal sentience has been proposed by LSE philosopher Jonathan Birch : "The idea is that when the evidence of sentience is inconclusive, we should 'give the animal the benefit of doubt' or 'err on the side of caution' in formulating animal protection legislation." Since we cannot reach absolute certainty with regards to the fact that some animals are sentient,

10881-459: The precautionary principle would be complete without brief reference to the difference between the precautionary principle and the precautionary approach . Principle 15 of the Rio Declaration 1992 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 be not used as

10998-612: The precautionary principle, is Telstra Corporation Limited v Hornsby Shire Council. The principle was summarised by reference to the NSW Protection of the Environment Administration Act 1991 , which itself provides a good definition of the principle: "If there are threats of serious or irreversible environmental damage, lack of full scientific certainty should not be used as a reasoning for postponing measures to prevent environmental degradation. In

11115-443: The primary cause of mishandling of biohazardous materials. Biosafety is also becoming a global concern and requires multilevel resources and international collaboration to monitor, prevent and correct accidents from unintended and malicious release and also to prevent that bioterrorists get their hands-on biologics sample to create biologic weapons of mass destruction. Even people outside of the health sector needs to be involved as in

11232-425: The principle can be seen in the public policy of requiring pharmaceutical companies to carry out clinical trials to show that new medications are safe. Oxford based philosopher Nick Bostrom discusses the idea of a future powerful superintelligence , and the risks should it attempt to gain atomic level control of matter. Application of the principle modifies the status of innovation and risk assessment : it

11349-679: The proponent of an activity, rather than the public, should bear the burden of proof. In February 2000, the Commission of the European Communities noted in a Communication from the Commission on the Precautionary Principle that "The precautionary principle is not defined in the Treaties of the European Union , which prescribes it [the Precautionary Principle] only once – to protect the environment. But in practice, its scope

11466-458: The publications recommended in 42 CFR 73.12. Therefore, training is the responsibility of lab employers and is not consistent across various laboratory types thereby increasing the risk of accidental release of biological hazards that pose serious health threats to the humans, animals and the ecosystem as a whole. Many government agencies have made guidelines and recommendations in an effort to increase biosafety measures across laboratories in

11583-422: The realm of God", as postulated by Prince Charles and Pope Benedict XVI . Many definitions of the precautionary principle exist: "precaution" may be defined as "caution in advance", "caution practiced in the context of uncertainty", or informed prudence . Two ideas lie at the core of the principle: One of the primary foundations of the precautionary principle, and globally accepted definitions, results from

11700-423: The responsible parties liable for environmental harm." Reversal of proof requires those proposing an activity to prove that the product, process or technology is sufficiently "safe" before approval is granted. Requiring proof of "no environmental harm" before any action proceeds implies the public is not prepared to accept any environmental risk, no matter what economic or social benefits may arise (Peterson, 2006). At

11817-465: 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. The "Advance Informed Agreement" (AIA) procedure applies to

11934-425: The risk of inhaling multi-walled carbon nanotubes. Appeals to the precautionary principle have often characterized the debates concerning animal sentience – that is, the question of whether animals are able to feel "subjective experiences with an attractive or aversive quality", such as pain, pleasure, happiness, or joy – in relation to the question of whether we should legally protect sentient animals. A version of

12051-491: The safety or operations manual and adhere to established practices and procedures. The laboratory supervisor is responsible for ensuring that all personnel have a clear understanding of these guidelines, and a copy of the safety or operations manual should be readily available within the laboratory. Finally, adequate medical assessment, monitoring, and treatment must be made available to all personnel when needed, and comprehensive medical records should be maintained. In June 2009,

12168-525: The same meaning, although in some particular cases an approach could be binding. A precautionary approach is a particular "lens" used to identify risk that every prudent person possesses (Recuerda, 2008) On 2 February 2000, the European Commission issued a Communication on the precautionary principle, in which it adopted a procedure for the application of this concept, but without giving a detailed definition of it. Paragraph 2 of article 191 of

12285-430: The same order should be considered sentient and should be thus legally protected. This is due to the fact that, on the one hand, "to investigate sentience separately in different orders" is feasible, whereas on the other hand, since some orders include thousands of species, it would be unfeasible to study their sentience separately. What is more, the evidential bar should be so low that only one indicator of sentience in

12402-425: The second part of the animal sentience precautionary principle, the decision rule concerns the requirement that we have to act once there is sufficient evidence of a seriously bad outcome. According to Birch, "we should aim to include within the scope of animal protection legislation all animals for which the evidence of sentience is sufficient, according to the standard of sufficiency outlined [above]". In other words,

12519-606: The species of a specific order will be sufficient in order for the precautionary principle to be applied. Such indicator should be "an observable phenomenon that experiments can be designed to detect, and it must be credible that the presence of this indicator is explained by sentience". Lists of such criteria already exist for detecting animal pain. The aim is to create analogous lists for other criteria of sentience, such as happiness, fear, or joy. The presence of one of these criteria should be demonstrated by means of experiments which must meet "the normal scientific standards". Regarding

12636-770: 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.' 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

12753-409: The threat." Respondents filed a motion for reconsideration in June 2013 and on 20 September 2013 the Court of Appeals chose to uphold their May decision saying the bt talong field trials violate the people's constitutional right to a "balanced and healthful ecology." The Supreme Court on 8 December 2015 permanently stopped the field testing for Bt (Bacillus thuringiensis) talong (eggplant), upholding

12870-607: The threatened organism rather than the nature of the threat. When biological warfare or new, currently hypothetical, threats (i.e., robots, new artificial bacteria) are considered, biosafety precautions are generally not sufficient. The new field of biosecurity addresses these complex threats. Biosafety level refers to the stringency of biocontainment precautions deemed necessary by the Centers for Disease Control and Prevention (CDC) for laboratory work with infectious materials. Typically, institutions that experiment with or create potentially harmful biological material will have

12987-556: The training in the hands of the employer. 22 states have approved Occupational Safety plans by OSHA that are audited annually for effectiveness. These plans apply to private and public sector workers, and not necessarily state/ government workers, and not all specifically have a comprehensive program for all aspects of biohazard management from start to finish. Sometimes biohazard management plans are limited only to workers in transportation specific job titles. The enforcement and training on such regulations can vary from lab to lab based on

13104-401: 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. 'Living modified organism intended for direct use as food or feed, or for processing (LMO-FFP)' are agricultural commodities from GM crops. Overall

13221-573: The various risk groups. Classification of biohazardous materials is subjective and the risk assessment is determined by the individuals most familiar with the specific characteristics of the organism. There are several factors taken into account when assessing an organism and the classification process. See World Health Organization Biosafety Laboratory Guidelines (4th edition, 2020): World Health Organization Biosafety Laboratory Guidelines Investigations have shown that there are hundreds of unreported biosafety accidents, with laboratories self-policing

13338-517: The work of the Rio Conference , or " Earth Summit " in 1992. Principle 15 of the Rio Declaration notes: 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 . In 1998,

13455-568: Was no reasonable likelihood of serious harm". Lack of this nuanced application makes the principle "self-cancelling" according to Stewart Brand , because "nothing is fully established" in science, starting from the precautionary principle itself and including "gravity or Darwinian evolution". A balanced application should ensure that "precautionary measures should be" only taken "during early stages" and as "relevant scientific evidence becomes established", regulatory measures should only respond to that evidence. Strong precaution holds that regulation

13572-463: Was promulgated in philosophy by Hans Jonas in his 1979 text, The Imperative of Responsibility , wherein Jonas argued that technology had altered the range of the impact of human action and, as such, ethics must be modified so that the far distant effects of one's actions should now be considered. His maxim is designed to embody the precautionary principle in its prescription that one should "Act so that

13689-688: 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 . The Cartagena Protocol on Biosafety, also known as the Biosafety Protocol, was adopted in January 2000, after

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