Problems
When we wanted to deliver our DNA sample, we were rejected by many express company. The reason why they rejected us was that they need our bio-safety assessment report of our sample. Sending our samples to quantified company to assess was so costly and the long process that we even couldn’t afford. In order to send our parts legally and make the process easily, we investigated professor, related government departments and the relevant legal codes.
More details about our investigation
Laws
We found some policies and laws about biosafety and biological products transportation in China.Here’s a list of part of them.
2005 No. 45 Command of Ministry of Health, PRC
Transportation management regulations of highly pathogenic microorganism bacterium or samples which can infect humans.
2006 No. 50 Command of Ministry of Health, PRC
Biological safety management methods of examination and approval for laboratory and experimental activities about highly pathogenic microorganisms which can spared through human.
2009 No. 68 Command of Ministry of Health, PRC
Biological safety management methods of culture preservation.
No. 8 Command of Ministry of Agriculture, PRC
It contain measures for the administration of agricultural genetically modified organism safety evaluation, safety classification of genetically modified crops, management and security monitoring of experiment.
No. 9 Command of Ministry of Agriculture, PRC
It contain import safety measures for the administration of agricultural genetically modified organisms, such as import and export formalities for examination and approval of agricultural GMOs used to study and test, produce and used as a feedstock.
No.160 Command of General Administration of Quality Supervision, Inspection and Quarantine, PRC
These regulations for the entry and exit health quarantine on special goods are carried out from this March, which don’t involve scientific research. While the original regulations mentioned that and gave a list of documents needed to declare.
Professor
Our instructor, Yan Wang, with particular understanding about our project, thinks that the project design meets the requirements of safety, for the reason that all our parts got from Risk Group 1 and are not related to pathogenicity. What’s more, he remind us to sterilize and don’t carry the biological products out of the lab.
Government
After our investigation, we decided to interview the government to receive the explanation of the unclear policies and laws. We tried to connect with Qingdao Municipal Government, Qingdao Municipal Health and Family Planning Commission, General Administration of Customs, Qingdao Custom District, General Administration of Quality Supervision, Inspection and Quarantine of PRC, Shandong Entry-Exit Inspection and Quarantine Bureau etc. And finally had interviews of Qingdao Municipal Health and Family Planning Commission, Qingdao Custom District and Shandong Entry-Exit Inspection and Quarantine Bureau.
Qingdao Municipal Health and Family Planning Commission told us that all labs related to pathogenic microorganism in Qingdao are under supervision of them according to biological safety management of the related provisions of the state. In recent years, there is no case about pathogenic microorganism transportation in Qingdao, if there will be, it must obey 2005 No. 45 Command of Ministry of Health, PRC. To avoid loss of human genetic resource, import of hazardous substance and ensure public health security, our country have strict administrative provisions, so there is no efficient way of examination and approval.
Officer of Qingdao Custom District told us gave us some advices. There is a fact that we, individuals, have many limitation in biological products transportation. Declaring the dry DNA at custom is a way to do it. But it always need many document from lab manager, university, and third party inspection agency inspection, if necessary, the Entry-Exit Inspection and Quarantine Bureau will have a spot check, which will take about a month. Or we can entrust our samples to biotechnology company and send aboard.
Current situation
The absence of relative laws
Biological product transportation is a kind of sensitive topic for almost all countries, which makes it a complicated-formalities affair. In China, there are a few policies and laws about it, but all of them refer to merchandise trade is, there is a vacuum in scientific research. This situation makes it a blur for many related departments and express companies. Because of it, many iGEM teams take a delusive way in transportation.
The cost of assessment is unaffordable
Sending biological product to biosafety assessment company to assess the biosecurity once costs at least 500 RMB and a month in Qingdao, Shandong. A month is a long period for a team to send parts to iGEM Foundation in time. What’s more, 500RMB once is a large amount of money for most teams.
Solution
When we in the dilemma, we found a solution to the transportation, which was a legal way without fraudulent description of goods. We successfully reached cooperation with GENEWIZ. They helped us extract plasmids and sequencing the samples we wanted to send to iGEM Foundation. On one hand, our parts were sent in a convenient and legal way, on the other hand, GENEWIZ could make sure our samples’ sequences were correct without any safety problems. It deserved to be mentioned that the biological productions in GENEWIZ were also need to be assessed the biosecurity.
Most noteworthy is the Reporter of each sample provided by GENEWIZ, which contains the gel image. It is a powerful certification shows our samples have the good quality.
Based on our investigation and our own successful experience, we made a protocol about the transportation to offer help if any team need.
Protocol
Plan A
Step 1: Send the sample to biosafety assessment company, for example Shanghai Research Institute of Chemical Industry (SRICI) and wait for the report.
Step 2: If the report says that sample is safe, and then take the sample with the report to the express company. After normal procedure, you can deliver your sample to iGEM Foundation
Plan B
Just one step!
Cooperate with a biotechnology company. You can negotiate with the company how many work they will do. And the most important point is that they will help you to assess and transport without the long period.
It’s very easy, convenient and fast!
