A new set of regulations taking effect Saturday will prohibit Chinese lab directors from allowing experiments on risky pathogenic microbes without approval.
The Chinese cabinet passed the 32-page and 72-item regulations in response to the incident in March when two people were infected by severe acute respiratory syndrome (SARS) virus at a lab of the Chinese Center for Disease Control and Prevention.
China will grade its pathogenic microbe labs by four levels. The first and second grades are labs forbidden to conduct experiments on risky pathogenic microbes, which can cause severe diseases in human and animals and easily spread, the regulations said.
The third and fourth grade of labs are off limits for experiments without special certificates from the health and veterinary medicine administrations, the regulations said.
These labs also must get approval from the administration when they plan to take up the experiments on risky pathogenic microbe and report the result when the research ends, the document added.
Early this year, the Diarrhea Virus Laboratory under the Institute of Virus Diseases of the center did experiments with the SARS virus without proper qualification and facilities to prevent the virus from spreading.
The administration found that the lab researchers used an untested method to kill the SARS virus and did not test the result of the process.
This was later confirmed as the source of SARS outbreak in China this year. The 2004 recurrence of SARS caused nine people to fall ill and one death.
The director and deputy director of the center resigned. The head and deputy head of the center's Institute of Virus Diseases as well as director of the lab were dismissed in July.
Now, according to the regulations, the head of the institution that owns a lab and head of the lab will be dismissed if a mistake like this happens again.
The biosafety regulations were the first and most authoritative one in China for medical labs, said an official with the Ministry of Health Saturday.
"The ministries of Health, of Agriculture and of Science and Technology all issued relevant documents and rules on this aspect but no standardized one was issued," he said, "We are working on a plan to implement the regulations."
Gao Qiang, executive vice-minister of health, said early July that strengthening lab biosafety is an important and urgent task for the national health system.
"The March outbreak sounds the alarm for the nation's lab safety management," Gao said. "The necessary punishment for some cadres is to help consolidate the responsibility awareness for relevant officials and establish a responsibility system for major accidents."
The regulations also ask medical labs to set up special departments or personnel to supervise the facilities. The labs must report to the superior administration if an accident takes place, the regulations said.
The first outbreak of SARS happened in early spring 2003 and a total of 5,327 cases were reported that year in 24 provincial areas on the mainland. Nearly 350 people died of the disease.
The Ministry of Health issued a plan to prevent SARS and bird flu this winter and next spring early this month, promising to send out experts within 24 hours after the first suspected case is found.
(Xinhua News Agency November 28, 2004)