BSL3 and BSL4 Agents: Epidemiology, Microbiology, and Practical Guidelines

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Despite effective vaccines, about to people die each year of seasonal influenza. In domestic poultry, certain subtypes become highly pathogenic and can be lethal for humans, but so far no highly pathogenic avian influenza HPAI virus acquired the ability of sustained human-to-human transmission. Several infected individuals developed a mild disease but one veterinarian died.

This chapter will focus on HPAI viruses, in particular H5N1, as it was, until recently, expected to cause the next pandemic. We use cookies in this website. She obtained her academic degree at the University of Leipzig and authored and co-authored in 25 national and international publications. Patrick Butaye is a senior researcher active at the Veterinary and Agrochemical Research center and a professor at the University of Ghent, Faculty of Veterinary medicine.

He obtained his academic degrees at the University of Ghent.

He authored and co-authored in more than 70 international scientific publications. She has since specialized in bacterial zoonoses including relapsing fever borreliosis, leptospirosis, rickettsiosis, brucellosis and Q fever. Much of her research is collaborative with developing countries. Pierce prize. He obtained his degree from the Johannes-Gutenberg University of Mainz working on the pathogenesis of Clostridium difficille. Ever since he has worked on developing rapid diagnostic tools for the detection of arboviruses and haemorrhagic fever viruses in cooperation with partners from third world countries.

He obtained the Abbot Diagnostic Award. He authored and co-authored 28 international scientific publications. Free Access. Summary PDF Request permissions. Two labs have been kicked out of the program, and five labs have been suspended from doing any select agent research, the agency said. Which labs repeatedly failed to address safety problems? The CDC won't name names — not even for the two labs kicked out of the select agent program. Yet earlier this year, the CDC publicly announced its suspension of the Tulane National Primate Research Center — after the center's accidental release of a bioterror bacterium became publicly known and was the subject of news reports.

The CDC said it balances the public's right to transparency with the risk posed by information being made available to those who might use it to threaten public health or security. Currently seven labs are under the extra scrutiny of a federal select agent lab performance improvement program, the CDC said. The program is offered as a voluntary alternative to suspension or other regulatory action, the agency said, for labs with a "repeated failure to correct past observation, biosafety and security concerns" or failures to comply with extra security requirements for work with "Tier 1" select agents.

Tier 1 agents are those deemed to pose the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating economic effects. While under scrutiny of the program, an individual researcher or project must halt the research that has been found in violation, but other select agent research at the institution generally is allowed to continue, the CDC said. Thirty-three labs have been put on performance improvement programs since , CDC said.

Their names are secret too. Dozens more labs have faced regulatory actions from the USDA, which takes the lead overseeing select agent labs primarily working with animal or agricultural pathogens. The USDA said all of its enforcement records about these fines are required to be kept secret because of the bioterrorism law.

The USDA did release a spreadsheet it says documents its actions, but the agency redacted almost all the information on it: lab names, violation types and even dates. Only a few references to warning letters and fines were spared the agency's black marker. The Federal Select Agent Program says no law or regulation bars the labs themselves from discussing their select agent research.

BSL3 and BSL4 agents; epidemiology, microbiology, and practical guidelines.

And universities and other research institutions routinely publish their research on select agent pathogens in scientific journals. Registered labs just aren't supposed to share details of specific security measures, such as locations of keys and codes, that would give access to pathogens.

The CDC and USDA said there is nothing that prohibits labs from releasing information or answering questions about any regulatory problems they've had.


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Yet few were willing to readilydiscuss violations or failed inspections. Although the secrecy provisions of the bioterrorism law apply only to certain federal agencies, officials at the state-run university cited that law among its reasons for denying requests for records about safety violations and the performance improvement program. The university wrote that being put on a PIP is something it is "proud" of. Last year, two labs agreed to pay fines handed down by the HHS Office of Inspector General for select agent violations, records show.

Lab director Paul Keim said the issues date back to when the university had difficulty keeping up with changing federal regulations. Since then the university's labs have passed several inspections, he said. The inspector general's office, citing regulations stemming from the bioterrorism law, redacted the names of these labs, as well as all other labs receiving fines, in documents it provided to USA TODAY under the Freedom of Information Act.

Other labs that have been fined over the years for select agent violations are located in Alabama, California, Missouri, South Dakota, Texas, Virginia and Wisconsin, records show. As a way of providing some oversight, Congress requires a report each year on the number of thefts, losses and releases of bioterror pathogens at labs regulated by the Federal Select Agent Program. Yet regulators provide scant details of their activities and the problems identified at labs.

Usually just three pages long plus a cover page, the reports contain only aggregated counts of lab incidents by type, plus vague information on a few serious incidents. Brucellosis is a contagious and economically significant agricultural disease — which causes cattle and other livestock to abort their fetuses, produce less milk, suffer weight loss, infertility and lameness. It has been the subject of eradication efforts for decades.

Louisiana, which had a case that year, had been declared brucellosis-free in In statements and interviews, LSU downplayed its violations and provided information that was later contradicted by federal records.

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USDA records show that investigators documented serious violations. The USDA also cited LSU for violating regulations by sending Brucella-infected cattle that had been part of select agent vaccine experiments to an unregistered slaughter facility where their meat was sold for human consumption.

LSU's Phil Elzer, who at the time ran the Brucella studies and now is a university administrator, said in an interview the practice of sending research cattle to slaughter was declared in the lab's operating procedures that were reviewed and signed off on at each inspection by Federal Select Agent Program regulators. In January , records show, the USDA sent a letter to LSU saying the case was being closed but reiterating the issues with the infected cow and the use of the unauthorized slaughter plant. Isaac added that the USDA suspended a portion of LSU's select agent registration because of the Brucella incident and "that portion of the registration is still suspended," Isaac said last fall.

For those labs not in the select agent program — and even those that are — self-policing is the front line of biosafety. Biosafety committees at research institutions, often staffed by scientists' colleagues, assess the risks of proposed research and grant or deny approval for studies.

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Labs also have other safety staff who may do internal inspections and lab audits, plus additional committees overseeing the use of animals in research. Yet some researchers appear ignorant of their institutions' biosafety rules. Others brazenly ignore repeated requests by biosafety staff to stop experiments and address issues. Documents obtained by the USA TODAY Network include at least 50 incidents since in which researchers were conducting experiments with genetically manipulated organisms without proper approval from internal safety committees.

CDC Laboratories – A Key Line of Defense

In some cases, records show researchers flaunting their institutional rules. The research was halted after veterinarians found several cages containing dead and dying mice, yet none of the cages was labeled with the infectious agent and they were in an area not approved for experiments with a BSL-2 pathogen.

The incident was "an extremely unusual event," said Sheila Champlin, an assistant vice chancellor at the center, noting corrective actions were taken before the scientist was allowed to resume research.

The biosafety officer ordered the investigator to stop all experiments, and the scientist was put on probation and received increased safety monitoring. The work was being done in a BSL-3 lab at the time it was discovered, but started in a BSL-2 lab, the safety officer's investigation found.