生物安全时代:新生物科技变革与国家安全治理*

科技进步改进了人类对天然生物危害因子的操控能力,在诱发新的生物安全危害形态的同时,也赋予了生物安全客体的源头难以追溯性、生物安全主体的多元性、生物安全危害演变机理的复杂性等特点。生物安全在很大程度上体现了非传统安全的非传统特点。随着生物科技与生物安全在推动人类社会发展进程的作用日益显著,21世纪或将成为生物安全的时代。新一轮生物科技变革及其与人类社会互动衍生的生物安全问题,已经逐渐触及人类安全观念和现代文明的内源性危机或挑战。全面提升国家生物安全能力、优化国家生物安全治理,不仅是世界各国的战略选择,也是对人类科技文明与政治文明的新探索。     

对两用生物技术发展现状与生物安全的思考

生命科技的蓬勃发展与全球化步伐的持续加速,为人类社会带来了诸多福祉。然而,生物技术的两用特征和传染病严峻的流行趋势带来了一系列生物安全隐患,引发了世界性的生物安全问题。随着国际形势的日趋复杂,生物安全这一非传统安全问题已成为国家安全体系的重要组成部分。本文通过分析典型两用生物技术的潜在威胁及新发突发传染病的发展趋势,指出我国生物安全领域面临的挑战性问题。同时结合研究发达国家在战略、政策与技术方面应对生物安全的重要举措,从战略布局、科技创新、团队建设、政策支持等方面为我国在两用生物技术的生物安全领域的发展提出建议。     

非洲：生物科技发展日趋重要

非洲是世界上生物科技最不发达的地区,现代生物科技在许多非洲国家还是新鲜事物。但近年来,非洲国家对生物科技的发展充分重视,不断加强生物人才培养,积极开展国际合作,高度重视生物安全,参与各种UNEP/GEF生物安全计划,并在非盟组织以及国际机构的引导和支持下,成立了生物科技高水平专家组（ABP）,撰写了“非洲生物技术发展报告”提出非洲生物技术发展构想。了解和研究非洲生物科技发展现状及动态对我国生物科技的发展以及开展中非合作有着重要的意义。     

疾病预防控制系统及医疗微生物实验室生物安全管理探析

目的:探寻医疗微生物实验室生物安全管理以及疾病预防控制系统的建设。方法:分析当前生物安全出现的原因及预防措施,采用列举的方法,对相关体系的完善提出建议。结果:由于传染病毒具有扩散块、毒力强的特点,因此生物安全的建设逐步受到社会的重视,其中疾病控制、疾病预防系统的建设及实验室的医疗安全检测具有格外重要的意义。通过调查发现,加强二者的安全管理,必须加强五个方面的建设,即严格遵守疾病控制系统与实验室安全管理规定,对有关的实验设备进行完善与升级,对实验室病菌实验严格把控,对医疗人员、技术人员及检验人员进行定期的安全培训,对实验室废弃物进行管理。讨论:由于当前传染病毒的危害越来越严重,因此,关注生物安全,完善相关的体系建设具有十分重要的意义,国家及医疗部门需要对此给予足够的重视。     

浅谈生物安全实验室安全事故的预防和有效控制

本文根据安全科学管理基础理论,事故分析、预测与预防理论,和人的不安全行为是导致与构成事故的要素原理,通过对生物安全实验室的安全管理和事故预防问题,及实验室生物危害事故的类型进行总结分析,阐述了生物安全实验室人为事故的预防及安全对策,并提出了如何对生物安全实验室安全事故进行超前预防、控制,从根本上消除事故隐患把安全事故的发生降低到最小限度的建议。     

基于DPSEEA模型构建生物安全评价体系：以深圳市为例

由于生物安全内涵外延和基本要素的模糊性、评价指标及评价方法的多元性等因素的限制, 我国至今尚未形成全面有效的生物安全评价指标体系。为构建生物安全评价体系, 研判生物安全现状, 本文首先运用规范分析法剖析《生物安全法》中有关“生物安全”定义的特点及不足, 从国家安全角度认为生物安全是指国家有效防范和应对危险生物因子及相关因素的威胁, 维护和保障自身安全与利益的能力和状态。明晰了生物安全的外延, 即只有对国家安全利益、民众健康、生态环境保护产生威胁的生物风险, 才是生物安全所规制的对象。其次, 生物安全基本要素包括自然生物安全和社会经济生物安全。自然生物安全主要指民众健康和生态环境保护方面, 包括生物个体安全和生物多样性安全。社会经济生物安全的关注点在国家安全利益, 即社会稳定和国家经济利益, 包括生物技术安全、生物实验室安全。第三, 以生物安全基本要素为管理对象的尺度, 将国家安全利益、民众健康和生态环境保护作为评价主体, 以生物法治为理念, 运用模型构建法, 将定性指标和定量指标相结合, 基于驱动力‒压力‒状态‒接触‒影响‒行动模型(driving force-pressure-state-exposure-effect-action, DPSEEA)构建了一套具有生物法治特色的生物安全评价指标体系, 包括生物安全法律法规体系健全水平、生物安全所涉违法犯罪行为的打击力度、生物安全各部门机构协调机制的建立和完善程度、符合规定标准的生物实验室数量和百分比、生物安全人才数量及密度、对生物产业和基本卫生部门的官方援助及其他途径投资总额、疫苗覆盖的目标人群比例、生物安全的宣传教育普及率8项评价指标在内共32项生物安全评价指标。最后, 基于实地调研及数据统计分析, 以2019年和2020年深圳生物安全工作为例对评价体系进行验证。结果显示, 深圳生物安全工作在农业生物安全、动植物防疫、防范外来物种入侵方面成果显著; 但仍在法律法规体系、生物安全人才培养和资金投入、生物安全普及率方面存在不足。针对上述问题提出完善生物安全法律法规体系并注重法律协调衔接、“一个健康”实现多元协同生物治理、加强人才培养和资金投入、加强生物安全宣传教育等建议。     

《生物安全法》实施背景下生物遗传资源的安全管理

生物安全是国家安全的重要组成部分,《中华人民共和国生物安全法》通过了全国人大常委会的审议,并自2021年4月15日起施行。生物遗传资源是国家可持续发展的重要战略资源和国家安全的重要物质保障,目前已成为世界各国资源争夺的新领域,随着生物技术、分子生物学、生物信息学的迅速发展,对生物遗传资源的安全管理,离不开法律法规等制度的规范。《生物安全法》的出台完善了中国的法律、法规等管理制度,但还需要进一步的细化。首先阐述了《生物安全法》的立法意义,介绍了《生物安全法》的层级地位及立法进程;然后,在《生物安全法》实施背景下简要分析了生物遗传资源的定义及其安全管理面临的问题、国内外生物遗传资源安全管理的现状,阐述了《生物安全法》的出台对完善中国生物遗传资源管理的重要意义;最后,从法律框架、法律法规内容和科学技术层面提出如何更好地推进与落实《生物安全法》出台后中国生物遗传资源的安全管理。     

我国生物安全科技工作成就与展望

生物安全是国家安全的重要组成部分,科技是国家生物安全的重要战略支撑。针对我国当前面临的重大生物安全威胁,科技部进行了一系列项目部署,不断加强生物安全科技支撑能力建设。本文重点总结了自"十二五"以来我国生物安全科技工作在重大新发突发传染病防控、外来物种入侵甄别与防控、实验室生物安全、生物安全特种资源库建设、基因合成与编辑技术等方面取得的主要成就,展望了前沿生物技术发展与学科交叉融合所带来的新型生物安全风险与防控机遇,并对我国生物安全科技发展提出建议。     

转基因植物中外源非目的基因片段的生物安全研究进展

生物安全（ｂｉｏｓａｆｅｔｙ）是指与以人类和环境为对象的生物学研究所产生的效应相关的安全性［1］,或对生物危害的检测、评价、监测、防范和治理的科学技术体系 ① 。遗传修饰生物体（ＧＭＯ）,特别是转基因植物的安全性是生物安全的重要内容,近几年已经引起政府、社会和科学界的广泛关注。转基因植物对人体健康的负面影响的考虑要点主要包括对人体的毒性、过敏原性、营养成分的改变与抗营养因子以及抗生素抗性等。对生态环境的负面影响即生态学风险的考虑要点包括转基因植物导致杂草问题,产生新病毒或加重病害,对非目标生物的影…     

农业生态安全及其生态管理对策探讨

对生态安全和农业生态安全的基本内涵进行了探讨。认为生态安全是指不同尺度的生态系统及其生物要素、环境要素、资源要素等在数量、质量及其相互作用关系上的一种和谐、健康、稳定的状态和水平。农业生态安全包括农业环境安全、农业资源安全、农业生物安全和农业产品安全等几个方面的内容。提出了一系列农业生态安全管理对策 ,包括 :①加强农业生态安全管理 ,发展生态产业 ;②加强对现有资源与生态系统的保护、培育与可持续利用 ;③保护农业生物多样性 ,保障生物安全 ;④加强农业综合抗灾能力建设 ;⑤加强农业生态安全监测与法律法规体系建设 ;⑥建立良好的、和谐的社会、经济和政治关系。     

Biosecurity in Scandinavia

This article investigates the extent to which biosecurity measures are recognized and have been implemented in the Nordic countries, in the absence of formalized security standards and legislation. Two trials were undertaken: first, a broad combined biosafety and biosecurity questionnaire survey of the Nordic countries, and, second, a focused on-site audit of 22 facilities, with 94 laboratories, in Denmark. Both trials indicated that external security had been partially implemented but that little attention had been paid to internal security and the establishment of biosecurity. It was demonstrated that the backgrounds and identities of insiders were rarely checked and that they could have gained access to both pathogen inventory lists and freezers in many facilities. In 81% of pathogen-containing facilities, pathogens were not routinely and centrally accounted for. The authors recommend the establishment of a legal framework congruent with international standards and obligations; novel governmental national biosecurity authorities, requiring a fusion of both microbiological and technical expertise and legislative powers; and the formulation of a new code of conduct termed "Good Biosecurity Practice."     

Biosecurity and yield improvement technologies are strategic complements in the fight against food insecurity

The delivery of food security via continued crop yield improvement alone is not an effective food security strategy, and must be supported by pre- and post-border biosecurity policies to guard against perverse outcomes. In the wake of the green revolution, yield gains have been in steady decline, while post-harvest crop losses have increased as a result of insufficiently resourced and uncoordinated efforts to control spoilage throughout global transport and storage networks. This paper focuses on the role that biosecurity is set to play in future food security by preventing both pre- and post-harvest losses, thereby protecting crop yield. We model biosecurity as a food security technology that may complement conventional yield improvement policies if the gains in global farm profits are sufficient to offset the costs of implementation and maintenance. Using phytosanitary measures that slow global spread of the Ug99 strain of wheat stem rust as an example of pre-border biosecurity risk mitigation and combining it with post-border surveillance and invasive alien species control efforts, we estimate global farm profitability may be improved by over US$4.5 billion per annum.     

Biosecurity and the review and publication of dual-use research of concern

Dual-use research of concern (DURC) is scientific research with significant potential for generating information that could be used to harm national security, the public health, or the environment. Editors responsible for journal policies and publication decisions play a vital role in ensuring that effective safeguards exist to cope with the risks of publishing scientific research with dual-use implications. We conducted an online survey of 127 chief editors of life science journals in 27 countries to examine their attitudes toward and experience with the review and publication of dual-use research of concern. Very few editors (11) had experience with biosecurity review, and no editor in our study reported having ever refused a submission on biosecurity grounds. Most respondents (74.8%) agreed that editors have a responsibility to consider biosecurity risks during the review process, but little consensus existed among editors on how to handle specific issues in the review and publication of research with potential dual-use implications. More work is needed to establish consensus on standards for the review and publication of dual-use research of concern in life science journals.     

Biosecurity for Translocations: Cirl Bunting (Emberiza cirlus), Fisher’s Estuarine Moth (Gortyna borelii lunata), Short-Haired Bumblebee (Bombus subterraneus) and Pool Frog (Pelophylax lessonae) Translocations as Case Studies

Exposure to parasites in conservation translocations increases the risks to recipient and translocated populations from disease, and therefore there has been interest in implementing biosecurity methods. Using four case examples we described how biosecurity was applied in practical translocation scenarios prior to and during a translocation and also post-release. We implemented biosecurity, including quarantine barriers, at specific points in the translocation pathway where hazards, identified by the disease risk analysis, had the potential to induce disease. Evidence that biosecurity protected translocated and recipient populations, included an absence of mortality associated with high-risk non-native parasites, a reduction in mortality associated with endemic parasites, the absence of high-risk pathogenic parasites, or associated diseases, at the destination; and the apparent absence of diseases in closely related species at the destination site. The biosecurity protocols did not alter the level or duration of translocated species confinement and therefore probably did not act as a stressor. There is a monetary cost involved in biosecurity but the epidemiological evidence suggests that conservation translocation managers should carefully consider its use. Breakdowns in quarantine have occurred in human hospitals despite considerable investment and training for health professionals, and we therefore judge that there is a need for training in the objectives and maintenance of quarantine barriers in conservation translocations. Biosecurity protocols for conservation translocations should be continually updated in response to findings from disease risk analysis and post-release disease surveillance and we recommend further studies to evaluate their effectiveness.

     

Ensuring the security of synthetic biology—towards a 5P governance strategy

Over recent years the label “synthetic biology” has been attached to a number of diverse research and commercial activities, ranging from the search for a minimal cell to the quick delivery of customized genes by DNA synthesis companies. Based on the analysis of biosecurity issues surrounding synthetic biology during the SYNBIOSAFE project, this paper will first provide a rationale for taking security, in addition to safety aspects of this new field, seriously. It will then take stock of the initiatives and measures that have already been taken in this area and will lastly try to map out future areas of activities in order to minimise the security risks emanating from this promising new field of scientific inquiry and technological progress.     

Biosecurity risk factors presented by international vessels: a statistical analysis

Invasive non-indigenous species are among the greatest threats to global biodiversity. Shipping is the principal vector for international dispersal of nonindigenous species, and shipping rates are increasing globally. The Australian government performs a range of regulatory actions to mitigate biosecurity risks associated with marine vessels, and in so doing has amassed a large volume of operational inspection data. This data can be used to quantitatively examine risk factors of vessels failing biosecurity procedures after arriving from international ports, the nature of biosecurity failures, and the types and seizure rates of biosecurity risk material (BRM). Classification trees with gradient boosting were used to assess characteristics that predict high risk vessels (n = 93,006) for carrying BRM, across 7 years of inspection data. Undeclared vessels and suspected irregular entry vessels posed the highest risk, but both were rare. Vessels that visit infrequently (<20 visits in 7 years) were common and had almost three times greater odds of failing inspection than vessels visiting frequently. On statistical analysis, yachts appeared to pose less risk than commercial vessels. In operational terms, a tentative profiled 20% fraction would contain 57% of genuine failures, and the concomitant non-screened group would contain 82% of passes. The most common reason for inspection failures was ballast water non-compliance (2.53%) and plant or insect detections (1.77%); biofouling was less common (0.13%) but testing for biofouling is not exhaustive. Invertebrate species comprised almost 90% of invasive organisms detected and seized from vessels failing biosecurity inspections. This study targets an entire transportation vector, which includes many pathways. Understanding the characteristics of transport vectors is pivotal to characterising the risk of biological invasions and applying adequate controls and prevention strategies. Our results show that biosecurity risk is not uniform on maritime pathways, so there is considerable scope for biosecurity regulators to impose risk-based intervention.     

Bio-safety and bio-security: A major global concern for ongoing COVID-19 pandemic

Besides its impacts on governance, economics, human culture, geostrategic partnership and environment, globalization greatly exerted control over science and security policies. Biosecurity is the critical job of efforts, policy and preparation to protect health of human, animal and environmental against any biological threats. With the transition into a global village, the possibility of biosecurity breaches has significantly increased. The COVID-19 pandemic is an example of an infringement on biosecurity that has posed a serious threat to the world. Since the first report on the recognition of COVID-19, a number of governments have taken preventive measures, like; lockdown, screening and early detection of suspected and implementing the required response to protect the loss of life and economy. Unfortunately, some of these measures have only recently been taken in some countries, which have contributed significantly to an increased morbidity and loss of life on a daily basis. In this article, the biological risks affecting human, animal and environmental conditions, biosafety violations and preventive measures have been discussed in order to reduce the outbreak and impacts of a pandemic like COVID-19.     

宠物与生物安全

宠物伴随人类文明已有数千年的历史。随着我国经济的增长和人们生活水平的不断提高,宠物饲养已日益普遍化。宠物种类和数量不断增加的同时,宠物的生物安全问题,已经明显地威胁到生物多样性、生态环境及人类健康。本文分析了宠物的潜在生物安全隐患,探讨了宠物生物安全管理方面存在的问题并提出了宠物生物安全的应对的措施。     

Biosecurity measures in 48 isolation facilities managing highly infectious diseases

Biosecurity measures are traditionally applied to laboratories, but they may also be usefully applied in highly specialized clinical settings, such as the isolation facilities for the management of patients with highly infectious diseases (eg, viral hemorrhagic fevers, SARS, smallpox, potentially severe pandemic flu, and MDR- and XDR-tuberculosis). In 2009 the European Network for Highly Infectious Diseases conducted a survey in 48 isolation facilities in 16 European countries to determine biosecurity measures for access control to the facility. Security personnel are present in 39 facilities (81%). In 35 facilities (73%), entrance to the isolation area is restricted; control methods include electronic keys, a PIN system, closed-circuit TV, and guards at the doors. In 25 facilities (52%), identification and registration of all staff entering and exiting the isolation area are required. Access control is used in most surveyed centers, but specific lacks exist in some facilities. Further data are needed to assess other biosecurity aspects, such as the security measures during the transportation of potentially contaminated materials and measures to address the risk of an "insider attack."     

Biosecurity on cattle farms: a study in north-west England

Background

Few studies have considered in detail the range of biosecurity practices undertaken on cattle farms, particularly within the UK. In this study, 56 cattle farmers in a 100 km² area of north-west England were questioned regarding their on-farm biosecurity practices, including those relating to animal movements, equipment sharing and companies and contractors visiting the farms.

Methodology/Principal Findings

There was great variation between farms in terms of the type of, and extent to which, biosecurity was carried out. For example, the majority of farmers did not isolate stock bought onto the farm, but a small proportion always isolated stock. Many farmers administered treatments post-movement, primarily vaccinations and anthelmintics, but very few farms reported carrying out any health checks after moving animals on. In addition, there appeared to be much variation in the amount of biosecurity carried out by the different companies and contractors visiting the farms. Deadstock collectors and contracted animal waste spreaders, although likely to have a high potential for contact with infectious agents, were reported to infrequently disinfect themselves and their vehicles.

Conclusions/Significance

These findings suggest that although certain biosecurity practices are undertaken, many are carried out infrequently or not at all. This may be due to many factors, including cost (in time and money), lack of proven efficacies of practices and lack of relevant education of veterinary surgeons, producers and other herd health specialists. Further research exploring the reasons for the lack of uptake is imperative if preventive medicine is to be utilised fully by the farming industry.