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JDR Vol.8 No.4 pp. 686-692
doi: 10.20965/jdr.2013.p0686
(2013)

Review:

Japanese Regulatory Space on Biosecurity and Dual Use Research of Concern

Tomohiko Makino

National Institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo 162-8640, Japan

Received:
June 21, 2013
Accepted:
July 19, 2013
Published:
August 1, 2013
Keywords:
dual use research of concern (DURC), biosecurity, surveillance, pathogen control, living modified organisms (LMO)
Abstract

Suspension of publishing A(H5N1) transmissibility study in 2011 revoked the dual use research of concern (DURC) in life science, which initially was triggered by the mousepox mutation research and anthrax letter event in 2001. Management in terms of biosecurity can be made in three entities: material, human, and information. Japanese legislations intensely provide material controls. The pathogen control by the infectious diseases control law categorizes pathogens and like substances of high concern into following four groups: Possession of Group 1 is prohibited, only exempted under the designation by the Ministry of Health, Labour and Welfare (MHLW). Possession of Group 2 needs prior permission by MHLW. Possession of Group 3 must be promptly reported to MHLW. Finally, possessors of Group 4 should comply with handling rules. Animal pathogens are also controlled by the Ministry of Agriculture, Forest and Fisheries. Conducting experiments that may handle genetic modifications is regulated by Cartagena Law. Although control of material are well managed as described above, control of human and information remains underdeveloped. There are no explicit legislations to clarify the security clearance of lab employees, nor investigational tracking of those who handle pathogens. Regarding informatic management, Japanese academic societies provoke DURC as the researchers’ code of ethics on disclosure of their research. But neither publication nor grant funding processes necessarily explore potential malicious use of outcomes. This article analyzed the A(H5N1) mutation research case. This analysis revealed that Japanese regulations, although working generally well, would have a pinhole when the genetic modification could enhance the pathogenicity and transmissibility to the extent that would elevate the tier of pathogen control groups. Japanese regulations will face the challenge of best managing potential harmful use of research without hindering the benefit from the advance of science.

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Last updated on Jul. 28, 2017