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

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Tulane will spend the next five years testing its outdoor monkey colony as well as wildlife and feral cats around the acre facility to ensure the bacteria haven't contaminated the environment. The CDC and Tulane say they think the bacteria spread only inside the center's buildings, and so far tests outdoors have not detected the bacterium, Burkholderia pseudomallei, which can cause severe and difficult-to-treat illness in people and animals infected by coming into contact with contaminated soil or water.

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

On a global scale, a lab accident is considered by many scientists to be the likely explanation for how an H1N1 flu strain re-emerged in that was so genetically similar to one that had disappeared before it looked as if it had been "preserved" over the decades. The re-emergence "was probably an accidental release from a laboratory source," according to a article in the New England Journal of Medicine. However, most pathogens studied in labs, unlike the flu, don't spread easily from person to person.

Often, to become infected a person needs to have direct contact with a pathogen, which is why lab workers are most at risk, experts said. For example, people can become infected with anthrax by inhaling the bacterium's spores, but once sickened they are not contagious, according to the CDC. Beyond accidental lab-associated outbreaks, federal auditors consider the deliberate theft and misuse of a deadly pathogen to be one of the most significant risks of biolab research.

That's what the FBI says happened in the anthrax letter attacks that killed five and sickened Bruce Ivins, a biologist and anthrax researcher at the U. The GAO, the investigative arm of Congress, has issued repeated warnings since that the proliferation of BSL-3 and BSL-4 laboratories has increased the aggregate risk of accidental or intentional releases of viruses, bacteria or toxins.

No single agency tracks the overall number or location of these labs, the GAO has said. Little is known about high-containment labs working with dangerous pathogens such as tuberculosis, the MERS virus and others that aren't on the select agent list and tracked by the Federal Select Agent Program. National standards for constructing and operating these kinds of labs are lacking, which means labs vary by local building requirements. While voluntary guidance exists for safe lab design and operations, the GAO has found it is not universally followed. The CDC's labs in Atlanta also have had airflow problems over the years, the newspaper previously reported.

Lab regulators at the Federal Select Agent Program — whose departments often fund the research they oversee — would not grant interviews despite repeated requests since last year. The two federal agencies that jointly run the program — the CDC and USDA — operate their own labs, which have been involved in recent high-profile incidents. USDA officials also declined to be interviewed. Lab safety officials at the National Institutes of Health, a major research funding agency that operates its own labs and helps set national biosafety guidelines, also declined interview requests.

Yet so much of select agent oversight is cloaked in secrecy, making it difficult to assess regulators' effectiveness in ensuring safety.

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In several instances, troubled labs and even federal regulators appeared to misrepresent the significance of the government's enforcement efforts. Since , the CDC has referred 79 labs for potential enforcement actions by the U. Some are repeat offenders. Five labs have had "multiple referrals" for enforcement actions, the CDC said.

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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.

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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.


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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.

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. We may be able to source a copy via our Interlibrary loans service: Complete our Book loan request form. Selected books available to borrow Enterohemorrhagic Escherichia coli and other shiga toxin-producing E. Hovde ed. Call Number: Covers a diverse array of topics, including microbial pathogenesis, disease pathophysiology, food safety, genetic analysis, veterinary microbiology, epidemiology, and environmental microbiology.

Leptospira and leptospirosis by Ben Adler ed.

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Topics include aspects of human and animal leptospirosis as well as detailed analyses of our current knowledge of leptospiral structure and physiology, epidemiology, pathogenesis, genomics, immunity and vaccines. Microbial growth in drinking-water supplies : problems, causes, control and research needs by Dirk van der Kooij, Paul W. Review This Product. Welcome to Loot. Checkout Your Cart Price. Add to cart. Description Details Customer Reviews In one handy book, this reference gathers all the necessary information on 14 of the most commonly used dangerous groups of pathogens in biosafety level 3 and 4 laboratories.

All the chapters are uniformly structured, with a brief overview of the microbiology, pathology, epidemiology and detection methods for each group. In addition, a whole chapter is devoted to the special biosafety requirements, disinfection, decontamination protocols, accident literature and accident procedures, as well as treatment options for all the organisms.

This chapter is clearly marked and easy to find when opening the book.