Bio-policy in China

Synthetic biology is one the most dynamic field in Life Sciences. It brings us opportunity to solve environment and health problems, but also brings us potential risks to us. In bio-policy part, we investigated the existing effective regulations in China and contrasted those with other regions. Regulation is a complex concept in China, which includes laws, administrative laws and regulations, judicial explanations, industry regulations. This part will give deep discussion on how they regulate researchers ‘actions in China and the insufficient of them.

Biosafety is an old topic for America and a young one for China. It originated between 1950s and 1960s in America. (Qi, 2006) People pay attention to it because they want to reduce the accidents among labs. In 1984, Centers for Disease Control (CDC) and National Institutes of Health (NIH) published Biosafety in Microbiological and Biomedical Laboratories and it became guidance document in America soon. It even became popular around the world.

However, Chinese realized the importance of biosafety later than that. In December, 1993, State Science and Technology Commission promulgated genetic engineering safety regulation, but the second article restricted the scope of genetic engineering within “directly inducing heterology DNA”.

Legislation process is slow, but the Severe Acute Respiratory Syndromes (SARS) triggered people and administrators’ attention in 2013 and speed up the legislation process, because some of the researchers were affected with it. (Yang, 2006)

In January, 2004, Regulation on the Bio-safety Management of Pathogenic Microbe Labs was published soon. This is a milestone and since then, many other detailed regulations were published, either. The regulations includes highly pathogenic microbes transportation regulation (《可感染人类的高致病性病原微生物菌（毒）种或样本运输管理规定》) in 2005 by Ministry of Health, interpersonal infectious catalogue (《人间传染的病原微生物名录》) in 2006 by Ministry of Health，Regulations on Administration of Agricultural Genetically Modified Organisms Safety(《农业转基因生物安全管理条例》) in 2001 by State Council, highly pathogenic microbes laboratory creature management rules(《人间传染的高致病性病原微生物实验室和实验活动生物安全审批管理办法》) in 2006 by Ministry of Health. These regulations are all restricted to the microorganism that is capable of causing human or animal diseases.

However, until now, there is not a specific regulation for synthetic biology. This phenomenon may be the result that the previous regulations for genetic engineering have covered the synthetic biology. However, synthetic biology has its own special features. The traditional regulations care less about homologous DNA transition. However, no one can guarantee that transfer several homologous DNA at a time is also safe.

Some institutions in China are trying their best to contribute to biosafety. In January, 2010, Chinese Academy of Sciences Institute of Botany held the first discussion about biosafety and held a second one in November, 2011. Synthetic biology regulation, management, related legislative suggestion (Guan, 2012)

To improve biosafety, there are many different ideas. Some people, such as Kelle (2009), called for self-regulation and they think that subjective motivation is more important than regulation. However, in the view of economics, rational person are driven by profits, tragedy of the commons occasionally happens. Government regulation plays an important way in control it. Hence, clear and reasonable regulations are the most powerful weapon to gain biosafety.

We think that we should promote the following aspects in China. First, we should make comprehensive regulation collections of biosafety. Second, we should make regulations on biosafety supervisory institutions. Risk assessment policy is also very important, because this can help to forecast the risk of a certain biobrick

References

Kelle, A. (2009) Security issues related to synthetic biology between threat perceptions and governance options. In: Synthetic Biology: The Technoscience and Its Societal Consequences (eds Schmidt M, Kelle A, Ganguli A, de Vriend H), Springer Academic Publishing: 101–119.

Guan, Z. J., Pei, L., Schmidt, M., Wei, W. (2012) Assessment and management of biosafety in synthetic biology. Biodiversity Science, 2012, 20 (2): 138–150.

Zhao, Z. H. (2009) Study of biosafety in pathogenic microorganism lab [病原微生物实验室生物安全管理对策浅探]. Disease Suveillance, 2009, 24(6):468.

Qi, G. M. (2006) Pathogenic microorganism Lab Biosafety [病原微生物实验室生物安全]. Beijing: People's Medical Publishing House.

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