Full-Scale Launch of Synthetic Biology as a National Strategy... Government Pre-Announces Enforcement Decree

Detailing public biofoundry and safety management standards... Act to take effect on April 23

The institutional framework to foster synthetic biology as a national strategic technology is now being fully activated. With the enforcement decree that simultaneously covers the promotion of research and development and the management of safety and responsibility being pre-announced for legislation, the execution base for synthetic biology and bio-manufacturing innovation has been made more concrete.

The Ministry of Science and ICT announced that, in order to define the matters delegated by the “Act on the Promotion of Synthetic Biology,” which is scheduled to take effect on April 23, it has prepared a draft enforcement decree of the Act and will pre-announce it for legislation for 40 days from the 23rd to April 6.

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The “Act on the Promotion of Synthetic Biology” passed the National Assembly in April last year through bipartisan agreement, with the aim of establishing a systematic national-level framework to promote synthetic biology research and development and to build a safety management foundation. The Ministry of Science and ICT explained that it drafted the enforcement decree after collecting opinions from experts in industry, academia, research institutes, and the legal community, so that the purpose of the law can operate effectively in the field.

Detailing implementation system, public infrastructure, and safety management standards

The draft enforcement decree is based on a fundamental direction of balancing the promotion of synthetic biology with safety and responsibility management. First, it clarifies the procedures and contents for establishing the basic plan and annual implementation plans, and specifies the standards for the composition and operation of the working-level promotion committee and the development council.

It also includes standards for operating research infrastructure. It establishes the legal basis for the designation and operation of synthetic biology research and development hub institutions and public biofoundries. A biofoundry is a research support facility that standardizes, accelerates, and automates the entire synthetic biology process, including design, build, test, and learn, and is regarded as a key infrastructure for research innovation and industrial diffusion.

In addition, it details a safety management system to minimize risks that may arise during the research process. By specifying the key items that must be reflected in research and development guidelines, as well as methods for safety management and monitoring, the government aims to enhance research reliability and social acceptance.

The Ministry of Science and ICT plans to collect opinions from stakeholders and the public during the pre-announcement period, then finalize the enforcement decree in line with the law’s effective date after consultations with relevant ministries and a review by the Ministry of Government Legislation.

On the same day, the Ministry of Science and ICT held the 5th general meeting of the “Korea Synthetic Biology Development Council,” a private sector-led consultative body, and shared the key contents of the Act and the enforcement decree. The Development Council was launched in July 2022 and currently has participation from more than 170 experts from industry, academia, and research institutes.

Koo Hyukchae, First Vice Minister of Science and ICT, said, “During the pre-announcement period, we will faithfully reflect opinions from the field to enhance the effectiveness of the system,” adding, “We will ensure that the follow-up procedures are carried out without a hitch so that the system operates stably in research and industrial settings.”

The pre-announced draft can be found on the “Legislation and Administrative Notices” bulletin board on the Ministry of Science and ICT website, and opinions can be submitted until April 6.