The Precautionary Principle in Practice: Applying the Ashford Framework to Technological Risk

The precautionary principle reflects an old adage — an ounce of prevention is worth a pound of cure. Its four central components include: taking preventative action in the face of uncertainty; shifting the burden of proof to proponents of an activity; exploring a wide range of alternatives to possibly harmful actions; and increasing public participation in decision processes. Scholars in a range of fields have identified U.S. environmental laws, regulations, and decisions exhibiting precaution de facto. This study moves beyond the traditional treatments of the subject, the morass of definitions systematizing precaution into its basic elements. It poses a further question, within the current legal system and existing laws, how might the precautionary principle be implemented by modifying aspects of a statute? By applying a conceptual legal precautionary framework to a specific example of technological risk management, Washington State's energy facility siting statute, we reveal deficiencies in four areas: compensation issues; burden of proof; Type I or II error preferences; and systematic comparisons. Supplying these would, in all likelihood, ensure a more effective statute and process as well as an outcome consistent with legislative goals. However, were an explicit statement of the precautionary principle introduced, parties dissatisfied with an outcome would seek judicial review, and extensive litigation could counter the legislative mandate of abundant energy at a reasonable cost.     

转基因生物相关平台的构建

在转基因生物全球化形势下,我国十分重视转基因生物安全管理及转基因生物安全性风险交流。通过建设转基因生物相关平台,可以加强我国转基因生物安全评价、转基因生物检测、风险交流及信息的整理和共享,拓宽我国转基因生物安全管理服务和信息交流渠道。平台主要由五部分组成,即:转基因生物安全性评价数据库、转基因生物安全检测方法数据库、转基因生物安全管理政策法规数据库、转基因生物检测服务子平台、公众风险交流子平台。平台的访问界面友好、美观、实用,能方便快捷地为用户提供信息查询和浏览等服务。平台可于此地址浏览:http://www.shgmo.org/。     

Precautionary Health Risk Assessment: Case Study of Biological Insecticides

In conventional risk assessment approaches, experts define the scientific questions that can legitimately be asked and the burden of proof is on the potentially exposed community to show that a proposal is unsafe. Here I propose an alternative approach, precautionary health risk assessment, in which the scientific questions to be addressed are defined by community consultation. I illustrate the approach with a case study of exposure to biological insecticides. This illustrates how community consultation can have a critical influence on the outcome of a health risk assessment. Government agencies may be reluctant to involve stakeholders in health risk assessments because this involves a loss of political control of the process. However, precautionary approaches are likely to lead to better health outcomes where decision stakes and scientific uncertainty are both high.     

Implications of the Precautionary Principle: Is it a Threat to Science?

Scientific research is of proven value to protecting public health and the environment from current and future problems. We explore the extent to which the Precautionary Principle is a threat to this rôle for science and technology. Not surprisingly for a relatively simple yet still incompletely defined concept, supporters of the Precautionary Principle come from different viewpoints, including a viewpoint that is at least uneasy with the rôle of science, and particularly its use in risk assessment. There are also aspects of the Precautionary Principle that inherently restrict obtaining and using science. The Hazardous Air Pollutant (HAP) provisions in the US Clean Air Act Amendments are an example of the Precautionary Principle, which both shifted the burden of proof so that the onus is now on showing a listed compound is harmless, and required maximum available control technology (MACT) instead of a primarily risk-based approach to pollution control. Since its passage in 1990 there has been a decrease in research funding for studies of HAPs. Other potential problems include that once MACT regulations are established, it may be difficult to develop new technological approaches that will further improve air pollution control; that by treating all regulated HAPs similarly, no distinction is made between those that provide a higher or lower risk; and that there is a perverse incentive to use less well studied agents that are not on the existing list. As acting on the Precautionary Principle inherently imposes significant costs for what is a potentially erroneous action, additional scientific study should be required to determine if the precautionary action was successful. If we are to maximize the value of the Precautionary Principle to public health and the environment, it is crucial that its impact not adversely affect the potent preventive rôle of science and technology.     

The Importance of Type II Error and Falsifiability

Aim. Before intergovernmental consensus under the Rio Declaration in 1992, ignorance of type I errors had been disfavoured in science. However, the Precautionary Principle (PP) counsels the avoidance of type II errors, rather than of type I errors. We need a new academic code for the PP. Material and methods. The risk of extinction has usually been evaluated based on conservative estimates of the present population size. I define the weight of evidence as the extinction risk of Japanese vascular plants based on unbiased estimates. Catch quotas in the fisheries are usually decided by precautionary approach. I calculate the long-term yield and risk of stock collapse under a simple stock dynamics model. Results. The weight of evidence depends on the frequency of grids with size unknown. In a few plant species, rankings based on conservative estimates have differed from rankings based on unbiased estimates. In fishery management, a catch quota based on a precautionary approach proved neither sufficient nor necessary to avoid stock collapse. The precautionary approach is one of the reasons that prevent us from maximizing a sustainable yield. Conclusions. We need to clarify the endpoint of risks, and check whether it is necessary to adopt a PP. We can obtain the weight of evidence that is measured under unbiased estimates, while the risk based on a PP is measured under conservative estimates.     

转基因大米品尝会:中国情境下的公众参与科学

以转基因大米品尝会为例,通过问卷调查、访谈法、观察法研究由公众主动发起的科学传播活动及其参与者。描述了该类活动的发起和组织过程,发现参与者是一群热爱科学、认同科学价值并愿意传播科学的人,他们的行动对自己、对亲友、对社会都产生了一定的影响。转基因大米品尝会以及类似的活动是转型期中国情境下的公众参与科学实践。     

Bioethics of public commenting: Manipulation,data risk,and public participation in E-Rulemaking

Little scholarly attention has been given to the ethics of public commenting as part of the online federal rule-making process. This essay argues the process of public commenting on federal regulations in the digital era threatens both the integrity of those regulations and the integrity of the individuals they are meant to protect. The ongoing risk is anonymous public commenting is open to manipulation. This risk is particularly salient for eRulemaking with implications for human subjects as was shown in the completed revision process to the Common Rule. Guarding against physical and informational harms requires at least some verification of the identities of public commenters. The burdens of verification access are outweighed by the benefits to authentic participation in e-Rulemaking.     

Precaution,threshold risk and public deliberation

It has been argued that the precautionary principle is incoherent and thus useless as a guide for regulatory policy. In a recent paper in Bioethics, Wareham and Nardini propose a response to the ‘precautionary paradox’ according to which the precautionary principle's usefulness for decision making in policy and regulation contexts can be justified by appeal to a probability threshold discriminating between negligible and non‐negligible risks. It would be of great significance to debates about risk and precaution if there were a sound method for determining a minimum probability threshold of negligible risk. This is what Wareham and Nardini aim to do. The novelty of their approach is that they suggest that such a threshold should be determined by a method of public deliberation. In this article I discuss the merits of Wareham and Nardini’s public deliberation method for determining thresholds. I raise an epistemic worry about the public deliberation method they suggest, and argue that their proposal is inadequate due to a hidden assumption that the acceptability of a risk can be completely analysed in terms of its probability.     

Regulatory science requirements of labeling of genetically modified food

This paper provides an overview of the evolution of food labeling in the USA. It briefly describes the three phases of agricultural development consisting of naturally occurring, cross-bred, and genetically engineered, edited or modified crops, otherwise known as Genetically Modified Organisms (GMO). It uses the Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims (MERSC) to evaluate the scientific validity of claims applicable to GMO and the Best Available Public Information (BAPI) to evaluate the pronouncements by public media and others. Subsequently claims on health risk, ecological risk, consumer choice, and corporate greed are evaluated based on BARS/MERSC and BAPI. The paper concludes by suggesting that labeling of food containing GMO should consider the consumer’s choice, such as the food used by those who desire kosher and halal food. Furthermore, the consumer choice is already met by the exclusion of GMO in organic food.     

The development and standardization of testing methods for genetically modified organisms and their derived products

As the worldwide commercialization of genetically modified organisms (GMOs) increases and consumers concern the safety of GMOs, many countries and regions are issuing labeling regulations on GMOs and their products. Analytical methods and their standardization for GM ingredients in foods and feed are essential for the implementation of labeling regulations. To date, the GMO testing methods are mainly based on the inserted DNA sequences and newly produced proteins in GMOs. This paper presents an overview of GMO testing methods as well as their standardization.     

Should Consensus Be ‘The Commission Method’ in the US? The Perspective of the Federal Advisory Committee Act,Regulations, and Case Law

This paper examines the drive for consensus from the perspective of the good government framework for federal advisory commissions in the United States. Specifically, the paper examines the Federal Advisory Committee Act (FACA)--the statute, its regulations, and case law. It shows that the FACA was intended to be an antidote to abuses in consensus-making processes, including the failure to fully include competing views on commissions. The index of suspicion in the FACA scheme rises when a group work product--including a consensus report--is to be the basis of recommendations to federal officials. Once FACA's requirements regarding committee composition are satisfied, the index of suspicion drops and FACA is indifferent to consensus-making; but the conditions for informed, meaningful participation apply to members who dissent from, as well as those who participate in, consensus. In negotiated rulemaking, the push for consensus and closure creates unacceptable tension with the good government goals of openness and accountability. Proponents of consensus-only bioethics commissions can learn from FACA-related legislative, agency, and judicial insights that consensus-seeking is not always desired by government officials; is rarely cost free; and that diversity and dissent enhance openness, accountability, and fairness. The burden of proof is therefore on proponents of a consensus-only standard for bioethics commissions to demonstrate that a drive for consensus furthers sound decision-making by government officials more than it sets back openness and accountability to a diverse public.     

GMDD: a database of GMO detection methods

Background  

Since more than one hundred events of genetically modified organisms (GMOs) have been developed and approved for commercialization in global area, the GMO analysis methods are essential for the enforcement of GMO labelling regulations. Protein and nucleic acid-based detection techniques have been developed and utilized for GMOs identification and quantification. However, the information for harmonization and standardization of GMO analysis methods at global level is needed.     

Factors Affecting Risk Perception of Electromagnetic Waves From 5G Network Base Stations

The coverage of the fifth-generation network has increased steadily since the network was introduced in 2019. However, public protests around the globe against the construction of 5G network base stations have continued to occur for fear that electromagnetic (EM) waves emitted from the stations would cause adverse health effects. To identify factors that have contributed to such increased risk perception, we conducted a cross-sectional study using data obtained from a survey that assessed Korean adults’ risk perception of EM wave-related objects. We found that female gender, high level of perceived exposure to EM waves, evaluation of public policies as ineffective, and high level of objective knowledge on EM waves were associated with increased risk perception. Furthermore, we found that higher ratings on a few risk characteristics such as “personal knowledge,” “seriousness of the risk to future generations,” “dreadfulness,” and “severity of consequences” were also associated with increased risk perception as well. Bioelectromagnetics. © 2020 The Authors. Bioelectromagnetics published by Wiley Periodicals LLC on behalf of Bioelectromagnetics Society     

从《生物安全议定书》审视我国基因修饰生物越境转移规则

基因修饰生物(GMO)越境转移对生物多样性保护和人类健康具有重要意义。《生物安全议定书》(议定书)分别5种情况对改性活生物体(LMO)越境转移予以不同的处理。我国行政法规和规章规定了一些GMO越境转移规则。以议定书为标准,可以观察出我国农业部和卫生部的相关规章也存在交叉和冲突,GMO越境转移规则体系尚待完善。     

Exploring the Determinants of the Perceived Risk of Food Allergies in Canada

Food allergies are emerging health risks in much of the Western world, and some evidence suggests prevalence is increasing. Despite lacking scientific consensus around prevalence and management, policies and regulations are being implemented in public spaces (e.g., schools). These policies have been criticized as extreme in the literature, in the media, and by the non-allergic population. Backlash appears to be resulting from different perceptions of risk between different groups. This article uses a recently assembled national dataset (n = 3,666) to explore how Canadians perceive the risks of food allergy. Analyses revealed that almost 20% self-report having an allergic person in the household, while the average respondent estimated the prevalence of food allergies in Canada to be 30%. Both of these measures overestimate the true clinically defined prevalence (7.5%), indicating an inflated public understanding of the risks of food allergies. Seventy percent reported food allergies to be substantial risks to the Canadian population. Multivariate logistic regression models revealed important determinants of risk perception including demographic, experience-based, attitudinal, and regional predictors. Results are discussed in terms of understanding emerging health risks in the post-industrial era, and implications for both policy and risk communication.     

Relative quantification in seed GMO analysis: state of art and bottlenecks

Reliable quantitative methods are needed to comply with current EU regulations on the mandatory labeling of genetically modified organisms (GMOs) and GMO-derived food and feed products with a minimum GMO content of 0.9 %. The implementation of EU Commission Recommendation 2004/787/EC on technical guidance for sampling and detection which meant as a helpful tool for the practical implementation of EC Regulation 1830/2003, which states that “the results of quantitative analysis should be expressed as the number of target DNA sequences per target taxon specific sequences calculated in terms of haploid genomes”. This has led to an intense debate on the type of calibrator best suitable for GMO quantification. The main question addressed in this review is whether reference materials and calibrators should be matrix based or whether pure DNA analytes should be used for relative quantification in GMO analysis. The state of the art, including the advantages and drawbacks, of using DNA plasmid (compared to genomic DNA reference materials) as calibrators, is widely described. In addition, the influence of the genetic structure of seeds on real-time PCR quantitative results obtained for seed lots is discussed. The specific composition of a seed kernel, the mode of inheritance, and the ploidy level ensure that there is discordance between a GMO % expressed as a haploid genome equivalent and a GMO % based on numbers of seeds. This means that a threshold fixed as a percentage of seeds cannot be used as such for RT-PCR. All critical points that affect the expression of the GMO content in seeds are discussed in this paper.     

Monitoring the presence of genetically modified food on the market of the Republic of Croatia

From the beginning of the human race people have been applying different methods to change the genetic material of either plants or animals in order to increase their yield as well as to improve the quality and quantity of food. Genetically modified organism (GMO) means an organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. Analysing the presence of GMO in food is done by detecting the presence of either specific DNA sequences inserted in the genome of transgenic organism, or detecting proteins as a result of the expression of the inserted DNA. In this work food testing for the presence of genetically modified organisms was conducted during the period from 2004 to 2007 in the GMO laboratory of the Croatian National Institute of Public Health. According to the regulations, among the samples in which the presence of GMO was detected, all those which had more than 0.9% of GMO content were either rejected from the border or removed from the market, because such GM food has to be appropriately labelled. Among the food samples which were analysed in 2004: 127 (2.37%) of a total of 1226 samples contained more than 0.9% of GMOs; in 2005 there was only one in 512 (0.20%) samples in total; in 2006 there were 4 out of 404 samples (0.99%), and in 2007: 7 of a total of 655 samples (1.07%) had GMO content above the allowed threshold of 0.9%.     

GM Risk Assessment

GM risk assessments (GMRAs) play an important role in the decision-making process surrounding the regulation, notification and permission to handle Genetically Modified Organisms (GMOs). Ultimately the role of each GMRA will be able to ensure the safe handling and containment of the GMO; and to asses any potential impacts on the environment and human health. A risk assessment should answer all “what if” scenarios, based on scientific evidence. This article sets out to provide researchers with helpful guidance notes on producing their own GMRA. While reference is made to UK and EU regulations, the underlying principles and points to consider are generic to most countries.     

A Microarray-based Detection System for Genetically Modified (GM) Food Ingredients

A multiplex DNA microarray chip was developed for simultaneous identification of nine genetically modified organisms (GMOs), five plant species and three GMO screening elements, i.e. the 35S promoter, the nos terminator and the nptII gene. The chips also include several controls, such as that for the possible presence of CaMV. The on-chip detection was performed directly with PCR amplified products. Particular emphasis was placed on the reduction of the number of PCR reactions required and on the number of primers present per amplification tube. The targets were biotin labelled and the arrays were detected using a colorimetric methodology. Specificity was provided by specific capture probes designed for each GMO and for the common screening elements. The sensitivity of the assay was tested by experiments carried out in five different laboratories. The limit of detection was lower than 0.3% GMO for all tests and in general around 0.1% for most GMOs. The chip detection system complies with the requirements of current EU regulations and other countries where thresholds are established for the labelling of GMO. Serge Leimanis, Marta Hernández, Sophie Fernández: These authors contributed equally to this paper.     

Spatial, seasonal and long-term variability of phytoplankton photosynthesis in lakes

A cross-system, worldwide approach has been used to ascertainthe spatial, seasonal and long-term variability of areal phytoplanktonphotosynthesis (PP) in lakes using published data sets. Also,the average fraction of annual PP occurring under ice is calculated.The lakes considered embrace a range of properties (depth, mixing,flushing rate, latitude and trophic status). The overall yearlyPP distribution is skewed to the left, suggesting the dominanceof low PP rates in the data set. When comparing lake types,no differences in average PP have been found among them. Inparticular, there are no clear areal PP differences among lakesof different trophic status on yearly, averaged basis, suggestingthat environmental limitations to PP also exist in lakes ofhigher trophic status. Volumetric-based PP can be better usedto outline PP-based trophic differences, but some degree ofoverlap is also apparent. Across all lake types (except in tropicallakes), the PP seasonal course experiences only one peak inthe year, but its timing is clearly different for each laketype. The seasonal variability of PP is lower in tropical lakes,as previously reported, but the variability of the other laketypes is roughly the same. Therefore, the effects of depth,mixing regime, flushing rate and nutrient status on PP seasonalityare difficult to ascertain since they appear to be counterbalancedby other more pervasive, local effects. Particularly, thereis no increase in temporal variability with the trophic statusof lakes, suggesting that PP seasonal control by physical variablesoverrides that of nutrients. Also, no significant relationshipbetween average PP and latitude has been found. Seasonal variabilityincreases as the yearly PP increases. On a relative basis, thereis a spatial gradient of seasonal variability of PP, which isweaker when seasonal variability of PP is considered in interyearcomparisons. Long-term (i.e. interannual) variability of PPis clearly related to increasing yearly averaged PP. Specifically,in temperate, stratifying lakes the seasonal time course ofPP is clearly different from that of phytoplankton biomass,suggesting an uncoupling of both variables as a result of differingP_max and losses throughout the year. On an average basis, environmentalvariables are poor predictors of areal daily PP, thereby implyingthat the interplay of factors is complex and changing throughoutthe year. PP under ice averages 10% of yearly PP, but its variabilityis high enough to make its measurement advisable.