my country's "Biological Safety Law" will be officially implemented soon，How to better promote the healthy development of biotechnology will continue to become an important topic for long -term exploration of biological safety legal systems in various countries。As a country that is developed earlier in biotechnology，The legislative regulation of biotechnology in the United States is also constantly developing。

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No doubt，Biotechnology research is for promoting public health and safety、Agriculture、Environment、Energy and national security is important。Some studies conducted for legal purposes have their value and benefits，But the knowledge generated by these studies、Information、Technology and products may be used for useful aspects，It may also be used for harmful aspects。Such studies are usually called "dual -purpose research" of biotechnology，Also known as "dual -use research"。These research risks may include the following aspects。

First，Double use of biotechnology may make the virus that has been destroyed "dead ash re -burning"。For example, scientists in 2005 based on reasons for studying antiviral drugs，Use genome editing technology to re -build the extinct "Spanish" influenza virus strain，The flu virus strain once triggered a major epidemic disease in 1918，Leading up to 50 million people to die。2，Dual purpose research on biotechnology may be used to develop new biological warfare agents or biochemical weapons。If synthetic biological technology can build a new hazardous virus or synthesize viruses with resistance to conventional medical measures or even more toxic virus，Escape the control measures for bet365 best casino games the existing in the international community for dangerous biological factors。third，Dual use of biotechnology can accelerate the production of hazardous biological agents。The continuously iterative upgraded biotechnology has greatly improved the efficiency of production related biotechnology products，Decrease in entry threshold，The operation is more convenient and easy，Easy to make large -scale mass production。fourth，Dual use of biotechnology can cause technology abuse and develop specific drugs。​​With the development of neuroscience and psychiatry，May affect human memory、Drugs of cognitive or emotional，Make people temporary or permanent disability。Fifth，Dual use of biotechnology may directly damage human health by enhancing some genetic functions。The original intention of the Editorial Infant incident such as He Jiankui genes may be to produce genes that resist AIDS virus，But the human health risks that may occur in the future have great uncertainties。

This "duality" of biotechnology，determines the "dilemma" situation of its regulatory methods。On the one hand，No development of biotechnology will greatly hinder human progress、Damage to human well -being，Such as synthetic pancitin、Vaccine, etc., depends on the progress of biotechnology; on the other hand，It is really difficult to develop biotechnology to eliminate the possibility of being misused or abused，This may cause fatal damage to the human body、Economic loss、Social confusion。This "duality" determines the biotechnology，Can't blindly prohibit its development，Can't fully let it develop，Instead, it is necessary to develop scientific, reasonable and healthy，and maximize the adverse effect on legal research。For this，The United States has adopted a regulatory strategy，Both want to maximize the research interests bet365 live casino games of biotechnology，And to maximize the risk of abuse of such research。

　　Government's external supervision regulations

March 29, 2012，The United States announced the "Regulatory Policy of the Double Research Institutions of Life Sciences"，This move established the US government's regulatory system for dual -use research risks，The transformation from product supervision mode to information knowledge full chain supervision mode，Clearly defined the life science research project that needs to be regulated，covering 15 biological factors and toxins and 7 types of experiments，The conventional review mechanism of a federal agency's specific research projects funded or carried out by the federal agency，Usually this type of project involves high -risk pathogen or toxin research，With potential dual -purpose research risks。The purpose of this policy is to reduce risk and collect the necessary information，Provide further support for the improvement of future policy。

The third part of the policy clearly lists the research on 15 pathogen toxins must be reviewed，such as bird flu virus (high pathogenic)、Anthuma Bacteria、Botox neurotoxin、Malack Berk Holde、Fake Berke Holde、Ipora virus、Foot -poly -poonal disease virus、Tulafrazus、Marburg Virus、Reform 1918 flu virus、Cowlag virus、Botox Bacterus Poison Base、Heavy ceiling virus、Light ceiling virus、Plagiarbolia。These pathogens or toxins have great risks that have been deliberately abused，May cause major casualties，Destruction of the economy，great impact on key infrastructure or public confidence。7 types of experiments involving the above viruses must be supervised: (1) to enhance the harmful effect of pathogens or toxins; (2) without clinical or agricultural certification，Destroy the immune mechanism for pathogens or toxins; (3) enable pathogens or toxins to resist clinical or agricultural preventive bet365 live casino games or therapeutic methods，or to avoid the detection method; (4) improve stability、The ability to spread or spread pathogen or toxins; (5) the range or orientation of the host or toxin of the pathogen or toxin; (6) enhance the sensitivity of the host group to the pathogen or toxins; The eliminated pathogen or toxins of the column。

The fourth part of the policy stipulates the supervision responsibility of the US government agency。First，U.S. government agencies should fully investigate biotechnology research projects belonging to the scope of supervision，and propose preliminary review suggestions and progress reports。2，Government agencies shall review and determine projects with dual -purpose research risks。third，The government should evaluate the risks and income of such projects，Research methods including such projects may bring risks，and must pay attention to the knowledge generated by public institutes、Information、Whether the product or technology will bring risks。fourth，Evaluation according to risk，Government institutions should discuss with the research institution，Formulate an operable risk relief plan，Take the necessary appropriate reduction of risk measures。It is clearly required to increase the relevant content of risk relief measures in the project research plan，Modify the design or process of research if necessary; take special or stricter biological safety measures; evaluate the effectiveness of existing medical response measures，Determine the effectiveness of medical response measures for such pathogens or toxins; carry out dual -purpose risk education to research institutions; conduct regular review of research institutions，Timely discover the dual -purpose risks that may exist in time; require research institutions to report newly discovered dual -purpose risks in a timely manner，and modify the risk relief plan as Bet365 app download needed; clarify the way of information transfer。Fifth，Government institutions shall request the research institution to submit annual reports，Determine whether there is a dual -purpose risk。If according to the above measures, it is not enough to reduce the risk caused by the institute，It is required that the research institution is required to limit the content of the content or the dissemination channel of the research results or research results，and even the final termination of the funding for research。Sixth，Government agencies should also report to the relevant management department for review results，Detailed reports of the number of dual -purpose risk research projects。Seventh，If necessary, government agencies should also consult the National Biological Safety Science Advisory Committee or hold a combat biological threat cross -institutional policy coordination meeting。

　　Internal supervision regulation of research institutions

September 24, 2014，The U.S. government released the new version of the "Supervision Policy of the Double Research Institutions of Life Sciences"，This policy takes effect after one year，The scope of supervision applicable to the research project that is not funded by the government in the United States，clarify how to determine the dual -purpose research at this level at this level，Standardize the specific practice of the research institution and the procedure rules that should be followed。This institutional supervision policy clarifies the funders of life science research and the research behavior and research exchange activities of responsible institutions and scientists who receive these funding。Because research institutions are usually the most capable of understanding the knowledge generated by the Institute of Biotechnology、Information、Dual purpose risks of products or technology，and is also most likely Bet365 lotto review to provide a method of relieving or maximizing the dual use risk of biotechnology。

This policy clarifies the supervision responsibility of the research institution。First，Research institutions shall establish and implement internal policies and practices of institutions，Identification and effective supervision dual -purpose risk。2，Research institutions shall designate the implementation of dual -purpose risk policies in the communication agency for special contacts。third，Research institutions shall establish an institution review team，Responsible for dual -use risk review。fourth，Research institutions shall provide people who are engaged in pathogens and toxins within the scope of supervision.。Fifth，Research institutions shall report to the situation that violates the dual -purpose risk supervision policy within the prescribed time limit，and the institutional relief measures taken to prevent similar violations of the rules。

Generally speaking，The legal regulations of the United States on the risk of dual use of biotechnology in the United States Except the holding of traditional hazardous biological factor products、Use、Circulation and export control，It also strengthened information、Knowledge、Supervision of Technology，cover the two aspects of government external supervision and internal supervision of research institutions，to ensure that the entire system is vigilant at the dual use of biotechnology.。But even so，We should still be soberly realized，Supervision cannot be equivalent to negative evaluations，Freedom of Life Science Research、Open，and extensive communication is important for the development of science。

　　(This article is the special project of Shanghai Political Science and Law Institute of Political Science and Law Prevention and Control Project "Dual Research Risk Law Regulations of Biotechnology" (2020yqfk04)、The National Social Science Fund major project "Research on the Construction of the Legal Fitting Legal System of GM Food Regulation in my country" (18zda147) phased achievement)

(Author Unit: School of Economics and Law, Shanghai School of Political Science and Law)