List of LMO Products that can be Imported – FAQ
What is LMO (Living Modified Organism)?
LMO (Living Modified Organism) is an organism that uses modern biotechnology to contain newly combined/assembled genetic substances. (See Article 2-2 of the LMO Act)
A. The technology of artificially recombining genes and injecting nuclear phases directly into the cells or the intracellular organelle.
B. Cell Fusion technology that goes beyond the scope of ‘family’ according to molecular taxonomy
What is a ‘LMO Research Facility’?
‘LMO Research Facilities’ refer to specific facilities that develops LMOs or conduct various experiments using them. All LMO Research Facilities must be legally reported or approved according to Article 22 of the LMO Act.
What happens if I violate the LMO Act?
If you violate the LMO Act, you will be sentenced to 1~5 years in prison, along with a fine of 10~70 million KRW depending on the case, under Articles 39 ~ 44 of the LMO Act.
If I purchase LMO products through your company, do I have to go through a separate import declaration, reporting process, etc.?
In principle, import declaration must be carried out in advance, and even if you import the LMOs through us, you still have to fill out all information related to the import declaration process. In addition, all customers who store and transport LMO products must fill out a LMO transportation management ledger.
If I wish to transport LMO products in Korea, what do I have to do?
For domestic transportation of LMOs, you must fill out & submit a transportation management ledger (including transportation of LMO for research purposes, transfer of LMO products from closed facilities, etc.). Also, if the LMO is to be moved for exhibition purposes, a LMO transportation plan (for exhibitions) (attached Form 2-1), shall be filled out and submitted. If the LMO is to be moved for testing/research purposes, a LMO transportation management ledger (for testing & research) (attached Form 2-8) shall be filled out and submitted.
Can I have the declaration confirmation letter?
Yes.
What if I lost the original copy of the declaration confirmation letter. What should I do?
The declaration confirmation letter can be reissued. If you send an e-mail to our customer support team, we will check your mail and provide you with an answer.
Are there any ‘dual-regulated’ (double-regulated) products, including the LMO Act?
Products may be subject to ‘dual-regulation’ (double-regulation), including the LMO Act. For example, products that include animal-derived cell-lines may be subject to both the LMO Act and animal-related laws/regulations.
When filling out a form (research facility & import declaration form) at a university, whose personal information should be entered in the ‘applicant’ column?
You shall enter the personal information of the representative of the institution (i.e., president of the university, head of the Industrial-Academic Cooperation Group, etc.), while the ‘Installation & Operation Manager/Director’ shall be stated in the name of the professor.
Is it possible to use a hand-written LMO Usage Plan & Safety Management Plan for the import declaration process?
Yes, however, we do not recommend it for the accuracy of the reports/documents.
Is there a ‘grading system’ for LMO facilities?
Yes, each LMO product has its own ‘grade’ based on its risk level (between Grade 1 ~ Grade 4). The standards that are used for the grading system can be seen in the table below.
There are multiple types of LMO products included in a single order. Do I have to proceed with the import declaration process for every single one of them?
Yes, we can provide an import declaration confirmation letter.
How often is the LMO product list updated?
The list is updated on the website in the first week of every month, so don’t forget to check on a regular basis.
I have requested an import declaration, but the client returned the document claiming that the information was wrong.
In the case of LMO declaration, the documents can be modified until the import declaration request is approved. However, please note that modification is difficult once the import declaration confirmation letter is issued.
Is it possible to use a hand-written LMO Usage Plan & Safety Management Plan for the import declaration process?
Yes, it is possible. However, we do not recommend it due to the risk of misinterpretation and delay of application caused by the additional time required to fill out the document.
Where can I make inquiries related to LMOs (for testing & research)?
The safety management of LMOs (for testing & research) are handled by the Ministry of Science and ICT (See Article 2 of the Enforcement Decree of the LMO Act).
If you have any inquiries related to this issue/topic, please contact the Research Environment Safety Team of the Ministry of Science and ICT or the Korea Research Institute of Bioscience and Biotechnology – National Research Safety Management HQ.
How can I check the safety management level of LMO (for testing & research)?
The LMO safety management level (for testing & research) is determined based on the classification of biohazard groups. Classification of biohazard risk groups are of living organisms are currently provided in Table 2 of the Genetic Recombination Experiment Guideline, which can be found at the Ministry of Government Legislation or ‘See Laws/Regulations’ page.
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