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发帖数: 518 | 1 Google翻译一次只能3900字符。
https://www.usatoday.com/story/news/2015/05/28/biolabs-pathogens-location-
incidents/26587505/
Investigation reveals hundreds of accidents, safety violations and near
misses put people at risk
Alison Young and Nick Penzenstadler, USA TODAY
Vials of bioterror bacteria have gone missing. Lab mice infected with deadly
viruses have escaped, and wild rodents have been found making nests with
research waste. Cattle infected in a university's vaccine experiments were
repeatedly sent to slaughter and their meat sold for human consumption. Gear
meant to protect lab workers from lethal viruses such as Ebola and bird flu
has failed, repeatedly.
A USA TODAY Network investigation reveals that hundreds of lab mistakes,
safety violations and near-miss incidents have occurred in biological
laboratories coast to coast in recent years, putting scientists, their
colleagues and sometimes even the public at risk.
Oversight of biological research labs is fragmented, often secretive and
largely self-policing, the investigation found. And even when research
facilities commit the most egregious safety or security breaches — as more
than 100 labs have — federal regulators keep their names secret.
Of particular concern are mishaps occurring at institutions working with the
world's most dangerous pathogens in biosafety level 3 and 4 labs — the two
highest levels of containment that have proliferated since the 9/11 terror
attacks in 2001. Yet there is no publicly available list of these labs, and
the scope of their research and safety records are largely unknown to most
state health departments charged with responding to disease outbreaks. Even
the federal government doesn't know where they all are, the Government
Accountability Office has warned for years.
A team of reporters who work for the USA TODAY Network of Gannett newspapers
and TV stations identified more than 200 of these high-containment lab
facilities in all 50 states and the District of Columbia operated by
government agencies, universities and private companies. They're scattered
across the country from the heart of New York City to a valley in Montana;
from an area near Seattle's Space Needle to just a few blocks from Kansas
City's Country Club Plaza restaurant and shopping district.
小瓶生物恐怖细菌已经不见了。实验室小鼠感染致命
病毒逃脱了，并发现了野生啮齿动物与
研究浪费。一所大学的疫苗实验中感染的牛是
多次被送去宰杀，并将其肉卖给人类食用。齿轮
旨在保护实验室工作人员免受致命病毒（例如埃博拉和禽流感）的侵害
多次失败。
今日美国网络调查显示，数百个实验室错误，
生物领域发生了安全违规事件和未遂事件
近年来，实验室一路走来，科学家们
同事，有时甚至是公众处于危险之中。
对生物研究实验室的监督是分散的，通常是秘密的，
调查发现，这在很大程度上是自我监管的。甚至当研究
设施犯下最严重的安全或安保违规行为
超过100个实验室-联邦监管机构对其名称保密。
特别令人担忧的是，与
生物安全3级和4级实验室中世界上最危险的病原体-这两个
自9/11恐怖以来，收容的最高水平
2001年遭到攻击。然而，这些实验室尚无公开可用的列表，并且
大多数人都不知道他们的研究范围和安全记录
国家卫生部门负责应对疾病暴发。甚至
联邦政府不知道他们都在哪里，政府
问责办公室已发出警告。
为Gannett报纸的USA TODAY网络工作的一组记者
和电视台确定了200多个这些高安全性实验室
由美国运营的所有50个州和哥伦比亚特区的设施
政府机构，大学和私人公司。他们分散了
从纽约市中心到蒙大拿州的山谷，遍布整个国家；
从西雅图太空针塔附近的区域到堪萨斯州仅几个街区
市的乡村俱乐部广场餐厅和购物区。
//
High-profile lab accidents last year with anthrax, Ebola and bird flu at the
Centers for Disease Control and Prevention and the discovery of forgotten
vials of deadly smallpox virus at the National Institutes of Health raised
widespread concerns about lab safety and security nationwide and whether
current oversight is adequate to protect workers and the public. Wednesday
the Department of Defense disclosed one of its labs in Utah mistakenly sent
samples of live anthrax -- instead of killed specimens – to labs across the
USA plus a military base in South Korea where 22 people are now being
treated with antibiotics because of their potential exposure to the
bioterror pathogen. As many as 18 labs in nine states received the samples,
the CDC said Thursday.
"What the CDC incidents showed us ... is that the very best labs are not
perfectly safe," says Marc Lipsitch, a Harvard University professor of
epidemiology. "If it can happen there, it certainly can happen anywhere."
10 incidents discovered at the nation's biolabs
Some people find little reassurance that nobody was sickened in the CDC
accidents or in the historically low numbers of serious infections among lab
workers generally, or that infections spreading into communities
surrounding labs have been rarer still.
"Many of us think that's really a matter of good fortune," said Beth Willis,
who chairs a citizen lab advisory panel in Frederick, Md., home to one of
the nation's largest high-containment research campuses at the Army's Fort
Detrick.
“You're talking about something that has the ability to take off and we
could not be confident of being able to contain it.”
David Relman, microbiology professor at Stanford
The country's best labs have robust safety programs, said Kenneth Berns, co-
chair of a panel of outside lab safety advisers currently examining
biosafety at CDC and other federal labs. Yet the systemic safety problems
identified at the CDC's prestigious labs have raised questions about what's
happening elsewhere. "It's a matter of some concern," said Berns, a
distinguished professor emeritus of molecular genetics and microbiology at
the University of Florida.
//
去年因炭疽，埃博拉和禽流感引起的实验室重大事故
疾病预防控制中心和遗忘者的发现
美国国立卫生研究院引发了致命的天花病毒小瓶
全国范围内对实验室安全和保障以及是否
当前的监督足以保护工人和公众。星期三
国防部透露，它在犹他州的一个实验室被错误地发送
活炭疽的样本-而不是杀死的标本-送到整个实验室
美国以及在韩国的军事基地，目前有22人
用抗生素治疗，因为它们可能接触
生物恐怖病原体。在九个州多达18个实验室收到了样品，
疾控中心周四表示。
“ CDC事件向我们展示的是……最好的实验室并没有
完全安全”，哈佛大学教授Marc Lipsitch说道
流行病学。 “如果能够在那发生，那肯定会在任何地方发生。”
全国生物实验室发现10起事件
某些人很难保证CDC中没有人生病
事故或实验室中严重感染的历史数量很少
工人或传染病蔓延到社区
周围的实验室还很少见。
“我们许多人认为这确实是一件好事，”贝丝·威利斯说，
他在马里兰州弗雷德里克（Frederick）担任公民实验室顾问小组主席，
美国陆军要塞最大的高防护性研究园区
德里克
“您所谈论的是具有起飞能力的东西，我们
对于能够容纳它充满信心。”
斯坦福大学微生物学教授David Relman
肯尼思·伯恩斯（Kenneth Berns）
目前正在检查的外部实验室安全顾问小组主席
CDC和其他联邦实验室的生物安全性。然而系统安全问题
在CDC的著名实验室中鉴定出的问题
发生在其他地方。 “这是一个令人担忧的问题，”伯恩斯说
著名的分子遗传学和微生物学名誉教授
佛罗里达大学。
//
The consequences could be devastating if accidents were to occur with lab-
created strains of deadly influenza viruses that are purposely engineered to
be easier to spread than what's found in nature, said David Relman, a
microbiology professor at Stanford University who is a federal adviser on
lab safety and a past president of the Infectious Diseases Society of
America.
"You're talking about something that has the ability to take off, and we
could not be confident of being able to contain it," he said.
Relman said that not enough is known about the state of safety at labs that
perform infectious disease research but emphasized that the kinds of labs
drawing concern are the same ones the public needs to discover important new
treatments and vaccines. "We have to find some happy blend of minimized
risk and enhanced benefit," he said.
Looking for a cure
Daily handling of deadly pathogens like Ebola, plague, anthrax
At the high-containment labs identified by USA TODAY, experiments are
underway involving drug-resistant tuberculosis, exotic strains of flu, the
SARS and MERS viruses, plague, anthrax, botulism, ricin and the Ebola and
Marburg hemorrhagic fever viruses, according to interviews and more than 20,
000 pages of internal lab safety records and incident reports obtained from
labs across the country.
Studies are also being done on a wide range of bioterrorism pathogens that
are less known to the public, such as the agents that cause exotic diseases
like tularemia, Q fever and melioidosis. Still others are focused on
pathogens that pose serious economic risks to agriculture, such as foot-and-
mouth disease, brucellosis and "mad cow" disease.
A USA TODAY Network investigation identifies more than 200 biosafety level 3
and 4 lab facilities that work with dangerous pathogens -- and reveals
safety records that some of them fought to keep secret.
//
如果实验室发生事故，后果可能是灾难性的。
创建了专门设计用于
大卫雷尔曼（David Relman）说，
斯坦福大学微生物学教授，是美国联邦政府的顾问
实验室安全和美国传染病学会的前任主席
美国。
“您所谈论的是具有起飞能力的产品，我们
不能控制它。”他说。
Relman说，对实验室的安全状态了解不足，
进行传染病研究，但强调实验室的种类
引起人们关注的是公众发现重要新事物的需求
治疗和疫苗。 “我们必须找到一些最小化的快乐融合
风险和增加的收益，”他说。
寻找治疗方法
每天处理致命病原体，如埃博拉，鼠疫，炭疽
在《今日美国》（USA TODAY）确定的高防护实验室中，
涉及抗药性结核病，外来流感病毒，
SARS和MERS病毒，鼠疫，炭疽，肉毒中毒，蓖麻毒蛋白和埃博拉病毒和
根据访谈，马尔堡出血热病毒有20多种，
从内部获取的000页内部实验室安全记录和事件报告
遍布全国的实验室。
还对各种生物恐怖主义病原体进行了研究，
很少为公众所知，例如导致外来疾病的媒介
像tularemia，Q发烧和类鼻osis病。还有一些人专注于
对农业构成严重经济风险的病原体，例如步行和
口腔疾病，布鲁氏菌病和“疯牛病”。
今日美国网络调查发现200多个生物安全等级3
和4个处理危险病原体的实验室设施-并揭示
一些人为保密而进行的安全记录。
//
At a few labs, experiments have been done with strains of flu and other
viruses purposely made to be more dangerous in studies that seek to
understand how they might mutate naturally. White House science advisers
called for a temporary halt of that kind of "gain of function" research last
fall while expert scientific panels spend the next year studying its risks
and benefits.
The research at BSL-3 and BSL-4 labs — which use special equipment,
negative air pressure and numerous safety and security procedures — seeks
to better understand how organisms cause disease and ways to protect against
them. It's the kind of work that the public doesn't give much thought to
until people with Ebola arrive on planes in the United States from an
outbreak in Africa, or the current avian flu outbreak forces farmers to kill
millions of chickens raising the specter of higher egg prices.
It's impossible to obtain a full accounting of lab accidents or lab-acquired
infections because there is no universal, mandatory requirement for
reporting them and no system to analyze trends to assess emerging biosafety
risks and disseminate lessons learned on a regular basis.
The Federal Select Agent Program, which inspects and regulates the subset of
research labs that experiment with about four dozen types of pathogens
deemed to pose bioterror threats, requires labs to report potential exposure
or release incidents, as well as thefts or losses of specimens.
From 2006 through 2013, labs notified federal regulators of about 1,500
incidents with select agent pathogens and, in more than 800 cases, workers
received medical treatment or evaluation, limited public data in program
annual reports show. Fifteen people contracted laboratory-acquired
infections and there were three unintended infections of animals, according
to the reports, which do not identify labs and mostly provide aggregated
counts of incidents by type. Reported incidents involve events ranging from
spills to failures of personal protective equipment or mechanical systems to
needle sticks and animal bites.
The program, jointly run by the Centers for Disease Control and Prevention
and the U.S. Department of Agriculture, refuses to release copies of
detailed incident reports, citing a 2002 bioterrorism law.
在一些实验室中，已经对流感病毒和其他菌株进行了实验
故意使病毒在旨在
了解他们如何自然变异。白宫科学顾问
最后呼吁暂时停止这种“功能获得”研究
下降，而专家级科学专家小组则花第二年研究其风险
和好处。
BSL-3和BSL-4实验室的研究-使用特殊设备，
负气压和众多安全措施-力求
更好地了解生物体如何引起疾病以及预防方法
他们。这是公众不多考虑的工作
直到埃博拉病毒患者从美国到达美国
非洲爆发或当前禽流感爆发迫使农民杀死
数百万只鸡提高了鸡蛋价格的幽灵。
无法获得对实验室事故或实验室获得的事故的完整核算
因为没有通用的强制性要求
报告它们，没有系统分析趋势以评估新兴的生物安全性
冒险并定期传播经验教训。
联邦精选代理计划，该计划检查并规范了
研究实验室，对大约四打类型的病原体进行实验
被认为构成生物恐怖威胁，需要实验室报告潜在的暴露
或释放事件，以及标本被盗或丢失。
从2006年到2013年，实验室向联邦监管机构通报了大约1500
选定病原体和800多个工人的事故
已接受治疗或评估，程序中的公共数据有限
年度报告显示。 15人与实验室取得合同
感染，据称有3种意外的动物感染
报告，这些报告无法识别实验室，并且大多提供汇总信息
按类型统计的事件数。报告的事件涉及以下事件：
泄漏到个人防护设备或机械系统的故障上
针刺和动物叮咬。
该计划由疾病预防控制中心联合运行
和美国农业部，拒绝发布
详细的事件报告，援引2002年生物恐怖主义法。
//
Incident records the USA TODAY Network obtained directly from individual
labs provide a window on the kinds of mistakes that happen. An animal
caretaker in Georgia was potentially exposed to a bird flu virus that kills
60% of the people it infects when a defective respirator hose supplying
purified air detached from its coupling in September. A researcher in
Wisconsin was quarantined for seven days in 2013 after a needle stick with a
version of the same H5N1 influenza virus. A lab worker in Colorado failed
to ensure specimens of the deadly bacterium Burkholderia pseudomallei had
been killed before shipping them in May 2014 to a co-worker in a lower-level
lab who handled them without critical protective gear. None of the workers
was infected.
The public and the lab community tend to learn only about the rare instances
of serious or fatal lab infections, which sometimes are published as case
reports in scientific journals or make national news.
In 2009, Malcolm Casadaban, a University of Chicago scientist with an
underlying medical condition, died from an infection with a weakened strain
of plague bacteria. In 2012, 25-year-old researcher Richard Din died after
being infected during vaccine research involving Neisseria meningitides
bacteria at a lab inside San Francisco's VA medical center. Both of their
deaths involved research in biosafety level 2 labs, where pathogens are
considered to be less dangerous than those worked with in high-containment
labs.
Richard Din, a 25-year-old researcher, died in 2012 after unknowingly
becoming infected by Neisseria meningitides at a lab inside San Francisco's
VA medical center.
Richard Din, a 25-year-old researcher, died in 2012 after unknowingly
becoming infected by Neisseria meningitides at a lab inside San Francisco's
VA medical center.
(Photo: Family photo)
事件记录直接从个人获得的今日美国网络
实验室为发生的各种错误提供了一个窗口。一只动物
佐治亚州的看守者可能接触了可杀死禽流感的病毒
呼吸软管供应不良时，它会感染60％的人
9月，纯净的空气从联轴器上脱离了。一位研究员
威斯康星州在2013年将一根针扎进去后隔离了7天
H5N1流感病毒的相同版本。科罗拉多州的一名实验室工人失败了
确保致命细菌假单胞伯克霍尔德氏菌的标本
在2014年5月将它们运送给较低级别的同事之前被杀死
实验室中没有关键防护装备的人。没有工人
被感染了。
公众和实验室界往往只了解稀有实例
严重或致命的实验室感染，有时会作为案例发布
以科学期刊报道或发布国家新闻。
2009年，芝加哥大学的科学家Malcolm Casadaban
潜在的医学疾病，死于菌株减弱感染
瘟疫细菌。 2012年，现年25岁的研究员Richard Din死于
在涉及脑膜炎奈瑟菌的疫苗研究期间被感染
旧金山弗吉尼亚州医疗中心内的实验室中的细菌。他们两个
死亡涉及生物安全性2级实验室的研究，其中病原体是
被认为比在高密环境中工作的人危险性低
实验室。
25岁的研究员Richard Din在不知不觉中于2012年去世
在旧金山市内的一个实验室被脑膜炎奈瑟菌感染
VA医疗中心。
25岁的研究员Richard Din在不知不觉中于2012年去世
在旧金山市内的一个实验室被脑膜炎奈瑟菌感染
VA医疗中心。
//
Din, who became a researcher to cure diseases like the cancer that killed
his mother, developed a fever and started feeling dizzy while out to dinner
with friends. He had no idea how serious his symptoms were, his friends and
family told USA TODAY. By morning, Din was covered in a splotchy rash and
could barely talk, recalled Lawrence Tsai, who raced to Din's apartment to
help.
Tsai carried his friend down two flights of stairs and drove him to the
hospital. "His body was very hard, very straight," Tsai said. "Only his eyes
were open. He could not say anything."
A few hours later, Din was dead. And Tsai said he and his friends were told
they, too, were at risk and needed to take antibiotics because of their
close contact with him. The bacteria that killed Din can spread from person
to person by direct contact with respiratory secretions. About two dozen
emergency room workers also were treated with antibiotics as a precaution,
according to a presentation about the case at a scientific conference.
Nobody else was sickened.
Federal workplace safety investigators, who investigated because the case
involved a death, said Din died because the VA failed to adequately
supervise and protect workers in the research lab. Among the "serious"
issues they cited: Din and other workers in the lab were manipulating
specimens of the dangerous bacteria out on tabletops — not inside
protective biosafety cabinets that would have reduced potential exposures to
droplets or splashes. The lab also failed to train workers about warning
signs of infection, violation records show.
Spreading into the community
While rare, an accidental release could be a disaster
丁（Din）成为治疗诸如致死性癌症等疾病的研究人员
他的母亲发烧并开始吃饭时感到头晕
和朋友。他不知道自己的症状有多严重，他的朋友和
一家人告诉《今日美国》。到了早上，丁被皮疹覆盖，
劳伦斯·蔡（Lawrence Tsai）回想起丁（Din）的公寓，
救命。
蔡带着他的朋友下了两层楼梯，把他开车到了。
医院。蔡说：“他的身体非常坚硬，非常挺直。” “只有他的眼睛
是开放的。他什么也没说。”
几个小时后，丁死了。蔡说他和他的朋友被告知
他们也有风险，因为他们
与他密切联系。杀死丁的细菌可从人传播
直接与呼吸道分泌物接触。大约两打
预防室的工作人员也接受了抗生素治疗，
根据科学会议上有关此案的介绍。
没有其他人感到不适。
联邦工作场所安全调查员，因为该案进行了调查
Din表示死亡，因为VA无法充分发挥作用
监督和保护研究实验室的工作人员。其中“严重”
他们引述的问题：Din和实验室中的其他工人正在操纵
危险细菌标本放在桌面上—不在内部
保护性生物安全柜，可减少潜在的暴露
水滴或飞溅。实验室也未能培训工人有关警告的信息
感染迹象，违规记录显示。
传播到社区
虽然很少见，但意外释放可能是一场灾难
//
Although lab-created outbreaks that spread to people or animals in the
surrounding community are rare, they have happened.
"That's what you would worry about," said Gigi Kwik Gronvall, of the UPMC
Center for Health Security, an independent think tank that studies
biosecurity and epidemics. "But even then the consequences up to now have
been limited to the very close contacts of the person who was infected."
A small, deadly outbreak of severe acute respiratory syndrome in China in
2004 was traced to lab workers at the National Institute of Virology in
Beijing. In 2007, an outbreak of foot and mouth disease among cattle in
England that required herds to be slaughtered was blamed on leaking drainage
pipes at a nearby research complex.
A guided tour of safeguards in biosafety labs.
In Louisiana, tests are underway to make sure a deadly bioterror bacterium
hasn't colonized the soil and water around the Tulane National Primate
Research Center near New Orleans. Late last year, the bacteria got out of
one of the center's BSL-3 labs, likely hitching a ride on workers' clothing,
sickening two monkeys that lived in outdoor cages and later infecting
others. Tulane will spend the next five years testing its outdoor monkey
colony as well as wildlife and feral cats around the 500-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.
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 1977 that was
so genetically similar to one that had disappeared before 1957 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 2009 article
in the New England Journal of Medicine.
尽管实验室造成的暴发传播到了人类或动物
周围的社区很少见，它们发生了。
UPMC的Gigi Kwik Gronvall说：“这就是您所担心的”
卫生安全中心，一个独立的研究智囊团
生物安全和流行病。 “但即使那样，后果至今
只限于被感染者的亲密接触。”
2004年中国一次致命的小暴发暴发。
2004年追溯到美国国立病毒学研究所的实验室工作人员
北京。 2007年，牛爆发了口蹄疫
要求将牛群宰杀的英国被指责为排水系统泄漏
附近研究大楼的管道。
生物安全实验室的安全保护导览。
在路易斯安那州，正在进行测试以确保致命的生物恐怖细菌
尚未在杜兰国家灵长类动物周围的土壤和水域定居
新奥尔良附近的研究中心。去年底，细菌从
该中心的BSL-3实验室之一，可能会搭上工人的衣服，
使两只生活在室外笼子里的猴子恶心，随后感染
其他。 Tulane将在未来五年内测试其户外猴子
占地500英亩的工厂周围的殖民地以及野生动物和野猫
确保细菌没有污染环境。 CDC和杜兰
说他们认为细菌仅在中心建筑物内传播，
到目前为止，户外测试尚未发现细菌，伯克霍尔德氏菌
假性马来酸，可能会导致严重而难以治疗的疾病
与受污染的土壤或动物接触而感染的人和动物
水。
在全球范围内，许多科学家认为实验室事故是最严重的事故。
H1N1流感毒株在1977年如何重新出现的可能解释是
在基因上类似于1957年之前消失的那只
如果它已经“保存”了几十年。重新出现“可能是
从实验室意外释放”，根据2009年的一篇文章
在新英格兰医学杂志上。
//
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.
“I don't think the public needs to be too concerned ... There are multiple
levels of checks and balances in place.”
Marian Downing, president, American Biological Safety Association
"I don't think the public needs to be too concerned," said Marian Downing,
president of the American Biological Safety Association. "There are multiple
levels of checks and balances in place."
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 2001 anthrax letter attacks that killed five and sickened 17. Bruce
Ivins, a biologist and anthrax researcher at the U.S. Army Medical Research
Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Md., was the
perpetrator, the FBI concluded.
The GAO, the investigative arm of Congress, has issued repeated warnings
since 2007 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.
但是，与流感不同，实验室中研究的大多数病原体都不容易传播
从一个人到另一个人。通常，要被感染，一个人需要拥有
直接接触病原体，这就是为什么实验室工作人员面临最高风险的原因，
专家说。例如，人们可以通过以下方式感染炭疽
吸入细菌的孢子，但是一旦生病，它们就不会传染，
根据CDC的说法。
“我认为公众不必太担心……有多个方面
制衡水平到位。”
美国生物安全协会主席玛丽安·唐宁（Marian Downing）
“我认为公众不必太担心”，玛丽安·唐宁（Marian Downing）说，
美国生物安全协会主席。 “有多个
制衡水平到位。”
除了实验室相关的意外爆发之外，联邦审计师还认为
故意盗窃和滥用致命病原体是最严重的病原体之一
生物实验室研究的重大风险。这就是联邦调查局所说的
2001年的炭疽信件袭击造成5人死亡，17人患病。Bruce
艾文斯（Ivins），美国陆军医学研究中心的生物学家和炭疽病研究人员
位于马里兰州迪特里克堡的传染病研究所（USAMRIID）
犯罪分子，联邦调查局得出结论。
国会调查部门GAO多次发出警告
自2007年以来，BSL-3和BSL-4实验室的数量激增
增加了意外或故意释放的总风险
病毒，细菌或毒素。
没有哪个机构可以追踪这些实验室的总数或位置，
GAO表示。与之合作的高安全性实验室知之甚少
危险病原体，例如结核病，MERS病毒和其他
不在选择代理人列表中，也不由联邦选择代理人跟踪
程序。
//
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 documents obtained by USA TODAY show power failures at BSL-3 labs at
Texas A&M University repeatedly resulted in the labs losing their negative
air pressure during 2013, a key safety feature that is among several used to
keep pathogens contained inside the lab. The CDC's labs in Atlanta also
have had airflow problems over the years, the newspaper previously reported.
"The public is concerned about these laboratories because exposing workers
and the public to dangerous pathogens, whether deliberate or accidental, can
have disastrous consequences," the GAO's Nancy Kingsbury told Congress at a
hearing on the CDC lab incidents last summer.
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 program oversees about 262
organizations that operate BSL-3 and eight organizations that operate BSL-4
labs.
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.
"We believe the current system of inspecting/overseeing laboratories is
adequate, but we are always open to continued improvements," the CDC said in
an emailed statement. USDA officials also declined to be interviewed.
建设和运营此类实验室的国家标准是
缺乏，这意味着实验室因当地建筑要求而异。而
对于安全的实验室设计和操作，存在自愿指南，GAO拥有
发现它不是普遍遵循的。
今日美国今日获得的文件显示BSL-3实验室的电源故障
得克萨斯州A＆M大学一再导致实验室失去了负面评价
2013年的空气压力，这是一项主要的安全功能，
将病原体保存在实验室内。 CDC在亚特兰大的实验室也
该报纸先前报道说，多年来一直存在气流问题。
“公众担心这些实验室，因为暴露了工人
公众面对危险的病原体，无论是故意的还是偶然的
会带来灾难性的后果。” GAO的Nancy Kingsbury在
去年夏天就CDC实验室事件进行了听证。
联邦精选代理商计划的实验室监管机构-其部门
经常资助他们所监督的研究-尽管
自去年以来重复请求。该计划监督约262个
运行BSL-3的组织和八个运行BSL-4的组织
实验室。
CDC和USDA这两个共同运行该计划的联邦机构
运营自己的实验室，这些实验室最近参与了
事件。
“我们认为目前的检查/监督实验室系统是
足够，但我们始终愿意继续改进。”
电子邮件声明。美国农业部官员也拒绝接受采访。
//
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.
"There is no 'zero-risk' proposition in the conduct of research," the agency
said in a statement. "NIH works extremely hard to minimize all research-
related risks."
Lab failures kept hidden
Key details of enforcement actions are secret
More than 100 labs experimenting with potential bioterror agents have been
cited by regulators at the CDC and USDA for serious safety and security
failings since 2003, USA TODAY has learned.
Yet so much of select agent oversight is cloaked in secrecy, making it
difficult to assess regulators' effectiveness in ensuring safety. In several
instances, troubled labs and even federal regulators appeared to
misrepresent the significance of the government's enforcement efforts.
Since 2003, the CDC has referred 79 labs for potential enforcement actions
by the U.S. Department of Health and Human Services' Office of Inspector
General. It has levied fines against 19 of them totaling more than $2.4
million, the CDC said in response to questions.
Some are repeat offenders. Five labs have had "multiple referrals" for
enforcement actions, the CDC said. 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.
The CDC and its regulatory partners at the USDA say the 2002 bioterrorism
law requires keeping this information secret.
美国国立卫生研究院的实验室安全官员进行了一项重大研究
拥有自己的实验室并帮助建立国家生物安全性的资助机构
准则，也拒绝了面试要求。
该机构说：“在研究过程中没有“零风险”主张。
在一份声明中说。 “美国国立卫生研究院非常努力地减少所有研究，
相关风险。”
实验室故障隐藏
执法行动的关键细节是秘密
已有100多个实验室在研究潜在的生物恐怖药
疾病预防控制中心和美国农业部监管机构援引严重安全保障
自2003年以来的失败，《今日美国》获悉。
然而，如此多的选择代理人监督都是保密的，因此
难以评估监管机构在确保安全方面的有效性。在几个
实例，陷入困境的实验室甚至联邦监管机构似乎
歪曲了政府执法工作的重要性。
自2003年以来，疾病预防控制中心已转介了79个实验室采取潜在的执法行动
由美国卫生与公共服务部的检查员办公室提供
一般。它对其中的19项罚款总计超过2.4美元
疾病预防控制中心在回答问题时说。
有些是屡犯。五个实验室有“多次推荐”
疾控中心说。两个实验室已被踢出
计划，五个实验室已被暂停执行任何选择代理程序
研究机构说。
哪些实验室屡屡未能解决安全问题？ CDC不会命名
名称-甚至对于被排除在选择代理程序之外的两个实验室也是如此。
CDC及其在USDA的监管合作伙伴表示2002年的生物恐怖主义
法律要求将此信息保密。
//
Residents of Frederick, Md., live near several high-containment labs located
at Fort Detrick. Some are concerned about the safety of research with
dangerous pathogens.
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
2008, 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 says it has conducted 48 investigations
that have resulted in $116,750 in fines.
马里兰州弗雷德里克（Frederick）的居民住在附近几个高级实验室附近
在德里特里克堡。有些人担心研究的安全性
危险的病原体。
然而，今年早些时候，疾控中心公开宣布暂停
杜兰国家灵长类动物研究中心-该中心意外发生后
释放生物恐怖细菌已成为众所周知的话题
新闻报道。疾控中心表示，它平衡了公众的透明权
信息泄露给那些可能
用它来威胁公共健康或安全。
目前，有七个实验室正在接受联邦精选代理商的额外审查
疾病预防控制中心说，实验室性能改进计划。该程序作为
除暂停或其他监管措施外，
该机构表示，对于“多次未能纠正过去的观察结果的实验室，
生物安全性问题”或未能遵守额外的安全性
与“第1层”选择代理配合使用的要求。一级代理商是那些
被认为具有最大程度地故意滥用的最大风险
大量人员伤亡或破坏性经济影响的巨大潜力。
在计划审查期间，单个研究人员或项目
必须中止被发现违反的研究，但其他选择
CDC通常允许该机构继续进行代理商研究
说过。
自从以来，已有33个实验室进行了性能改进计划
CDC表示，2008年。他们的名字也是秘密的。
数十个实验室已面临美国农业部的监管行动，
负责监督精选代理商实验室的主要负责动物或动物研究的实验室
农业病原体。美国农业部表示已经进行了48次调查
导致罚款$ 116,750。
//
The USDA said all of its enforcement records about these fines are required
to be kept secret because of the 2002 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. 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.
Labs at the University of Hawaii-Manoa are among those in the federal
performance improvement program, at least as of January, records obtained by
USA TODAY show. Although the secrecy provisions of the 2002 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 inadvertently confirmed that its Honolulu labs had been put
in the performance improvement program in records it filed in January with
Hawaii's Office of Information Practices, which is deciding USA TODAY's
public records appeal. The university wrote that being put on a PIP is
something it is "proud" of.
美国农业部说，所有关于这些罚款的执法记录都是必需的
由于2002年的生物恐怖主义法而被保密。美国农业部确实发布了
电子表格说它记录了其行动，但该机构几乎编辑了
上面的所有信息：实验室名称，违规类型甚至日期。只要
几处提到警告信和罚款的机构没有被黑
标记。
联邦选择代理计划说没有法律或法规禁止实验室
讨论他们的特工研究。还有大学和
其他研究机构会定期发布有关特定研究的信息
科学期刊中的病原体代理。
注册实验室不应该共享特定安全性的详细信息
可以访问的措施，例如键和代码的位置
病原体。疾病预防控制中心和美国农业部说，没有什么可以禁止实验室
发布信息或回答有关任何法规问题的问题
他们有。然而，很少有人愿意讨论违规或失败的情况
检查。
夏威夷-马诺阿大学的实验室属于联邦实验室
绩效改进计划，至少从一月份开始，
今日美国秀。虽然2002年生物恐怖主义的保密规定
法律仅适用于某些联邦机构，国营官员
大学引用该法律作为拒绝记录要求的原因之一
有关安全违规和性能改进计划的信息。
该大学在无意中确认其檀香山实验室已被放置
在绩效改进计划中记录在1月份提交的记录中
夏威夷州信息实践办公室正在决定《今日美国》的
公共记录上诉。该大学写道，被放在PIP上是
它是“骄傲”的。
//
"We do not believe entering into the program is an embarrassment, we think
it should be showcased, but that would be improper because as participants
in the Federal Select Agent Program, we are obligated to keep this
information private," the university wrote to the appeals agency, adding
that it "has been an exemplary participant in the Federal Select Agent
Program."
University of Hawaii officials declined to be interviewed.
Last year, two labs agreed to pay fines handed down by the HHS Office of
Inspector General for select agent violations, records show.
A lab that federal officials would describe only as an "Arizona research
university" agreed in 2014 to pay a $165,000 fine for failing to keep
accurate inventory records for select agents and not having biosafety
procedures adequate for the risks associated with the pathogens they worked
with. The lab, the USA TODAY Network's reporting found, was Northern Arizona
University in Flagstaff. Lab director Paul Keim said the issues date back
to 2010 when the university had difficulty keeping up with changing federal
regulations. Since then the university's labs have passed several
inspections, he said.
An unnamed Florida laboratory agreed to pay $50,000 to resolve violations
that included failing to ensure accurate inventories of select agents and
failing to notify the CDC and appropriate law enforcement agencies after
discovering a missing select agent.
The inspector general's office, citing regulations stemming from the 2002
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.
Congress gets limited, wrong information
A $425,000 fine that disappeared
“我们认为加入该计划并不令人尴尬，我们认为
应该展示它，但这将是不合适的，因为作为参与者
在联邦精选代理计划中，我们有义务保留此
私人信息”，大学写给上诉机构，并补充说
它“曾是联邦选择代理人的模范参与者
程序。”
夏威夷大学官员拒绝接受采访。
去年，两个实验室同意支付HHS办公室下达的罚款。
监察长针对选定代理人的违规行为，记录显示。
联邦官员只能将实验室描述为“亚利桑那州的研究
大学”在2014年同意支付$ 165,000的罚款，原因是未遵守
特定代理商的准确库存记录，并且没有生物安全性
足以应对与其工作的病原体有关的风险的程序
用。 《今日美国网络》报道发现的实验室位于北亚利桑那州
弗拉格斯塔夫大学。实验室主任Paul Keim说问题可以追溯到
到2010年，当时大学难以跟上不断变化的联邦制的步伐
规定。从那以后，大学的实验室已经通过了几次
他说。
佛罗里达一家匿名实验室同意支付50,000美元解决违规行为
其中包括未能确保精选代理商的准确库存，以及
未能通知疾病预防控制中心和适当的执法机构
发现缺少的选择代理。
监察长办公室引用2002年的法规
生物恐怖主义法，删除了这些实验室以及所有其他实验室的名称
实验室在根据《今日美国》提供给美国的文件中收到罚款
信息自由法。多年来被罚款的其他实验室
某些特工的违规行为位于加利福尼亚州阿拉巴马州，密苏里州，
记录显示，南达科他州，德克萨斯州，弗吉尼亚州和威斯康星州。
国会信息有限，信息错误
425,000美元的罚款消失了
//
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.
The select agent program told Congress it had "imposed a $425,000 civil
money penalty" on an unnamed lab where a serious biosafety lapse in 2008 had
resulted in a cow in a nearby disease-free herd becoming infected with
Brucella bacteria, which cause brucellosis.
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.
The $425,000 fine would have been one of the largest in the overall select
agent program's history — if it had actually been imposed.
But it wasn't imposed, USA TODAY's investigation found, and the USDA never
corrected the record with Congress.
Despite the risks, researchers at the Virginia Division of Consolidated
Laboratory Services are committed to their jobs. They are well trained and
say that training is the key to safety.
为了提供一些监督，国会每年都需要一份报告
实验室中生物恐怖病原体被盗，损失和释放的数量
受联邦精选代理商计划的监管。
然而，监管机构提供的活动和问题的细节很少
在实验室确定。通常只有三页，外加封面，
报告仅按类型包含实验室事件的汇总计数，加上模糊的
有关一些严重事件的信息。
特工计划告诉国会，它“已征收425,000美元的民事赔偿金
一家未具名的实验室被判处“罚款”
导致附近的无病牛群中的一头牛感染了
布鲁氏菌，引起布鲁氏菌病。
布鲁氏菌病是具有传染性和经济意义的农业
疾病-导致牛和其他牲畜堕胎，
产生的牛奶减少，体重减轻，不育和la行。它一直
数十年来根除工作的主题。
$ 425,000的罚款将是全部精选中最高的罚款之一
代理程序的历史记录-如果确实实施过。
但这不是强制性的，《今日美国》的调查发现，美国农业部从未
与国会更正了记录。
尽管存在风险，但维吉尼亚州综合事业部的研究人员
实验室服务致力于他们的工作。他们训练有素，
说培训是安全的关键。
//
USA TODAY was able to identify the Brucella research program at Louisiana
State University's AgCenter in Baton Rouge as the likely recipient of the $
425,000 fine by examining USDA animal health reports that tallied what
states reported brucellosis cases in 2008. Louisiana, which had a case that
year, had been declared brucellosis-free in 2000.
LSU officials spent months denying USA TODAY access to its records about the
incident, citing among other things select agent regulations unrelated to
the requested information. In statements and interviews, LSU downplayed its
violations and provided information that was later contradicted by federal
records.
"The incident was not found to be caused by a violation of federal
regulations; no fines were imposed upon LSU, and the regulatory agencies had
uncertainty as to whether the strain of bacteria in the affected cow was
the same strain that was being used in the LSU research," LSU officials said
in a November 2014 email to USA TODAY.
Yet, in December 2014, when USA TODAY received copies of the incident
investigation reports from the USDA and Louisiana's state agriculture
department, the documents showed no uncertainty.
USDA records show that investigators documented serious violations. In
levying the $425,000 fine, regulators cited LSU for failing to have adequate
biosafety measures, resulting in the release of the bacteria that caused
the cow's infection. The USDA also cited LSU for violating regulations by
sending Brucella-infected cattle that had been part of select agent vaccine
experiments to an unregistered slaughter facility where their meat was sold
for human consumption.
今日美国能够确定路易斯安那州的布鲁切拉研究计划
州立大学位于巴吞鲁日的AgCenter可能是$
通过检查USDA动物健康报告对425,000罚款
州在2008年报告了布鲁氏菌病病例。
年，在2000年被宣布为无布鲁氏菌病。
路易斯安那州立大学（LSU）官员花了数月时间拒绝《今日美国》访问其有关
事件，除其他外，引用与之无关的代理商规则
要求的信息。在声明和采访中，路易斯安那州立大学轻描淡写了
违规行为，并提供了后来与联邦政府相抵触的信息
记录。
“未发现事件是由于违反联邦法规引起的
规定； LSU没有被罚款，监管机构有
患病母牛中细菌菌株是否为
LSU研究中使用的相同菌株，” LSU官员说
在2014年11月发送给今日美国的电子邮件中。
然而，在2014年12月，《今日美国》收到事件的副本
美国农业部和路易斯安那州农业的调查报告
部门，文件显示没有不确定性。
USDA记录显示调查人员记录了严重的违规行为。在
征收$ 425,000罚款，监管机构引用LSU未能提供足够的罚款
生物安全措施，导致细菌释放
牛的感染。美国农业部还引用LSU违反了
运送曾被布鲁氏菌感染的牛作为选择剂疫苗的一部分
在未经注册的屠宰场进行实验，在那里出售肉类
供人类食用。
//
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. "To all of a sudden say we were doing it wrong was
very surprising," Elzer said. LSU appealed, and the USDA eventually dropped
the fine, he said.
In January 2010, 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.
USDA officials acknowledge that they never imposed the $425,000 fine and
made a mistake touting it in their report to Congress.
"It should have stated that we were proposing a fine, instead of stating we
issued a fine," said Freeda Isaac, USDA's director of Agriculture Select
Agent Services, in an emailed statement. 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.
Limitations of self-policing
Some researchers ignore biosafety rules
路易斯安那州立大学的菲尔·埃尔泽（Phil Elzer），当时负责布鲁切拉研究，现在是
一名
大学管理员在接受采访时说发送的做法
在实验室的操作程序中宣布要宰杀研究牛
在联邦检查局的每次检查中均已审核并签字
代理商计划监管者。 “突然说我们做错了
Elzer说。” LSU上诉，USDA最终下跌
他说，罚款。
记录显示，2010年1月，美国农业部致函路易斯安那州立大学
已关闭，但重申感染牛和
使用未经授权的屠宰场。
美国农业部官员承认，他们从未对425,000美元的罚款和
在向国会提交的报告中称其为错误。
“它应该说我们在提议罚款，而不是说我们
处以罚款”，美国农业部农业部部长Freeda Isaac说道
代理服务，通过电子邮件发送。艾萨克补充说，美国农业部已暂停
由于布鲁切拉（Luccella），LSU的部分选择代理注册
事件和“该部分注册仍被暂停”，以撒
去年秋天说。
自我监管的局限性
一些研究人员无视生物安全规则
//
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. 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.
Universities, feds fight to keep lab failings secret
Documents obtained by the USA TODAY Network include at least 50 incidents
since 2012 in which researchers were conducting experiments with genetically
manipulated organisms without proper approval from internal safety
committees. In some cases, records show researchers flaunting their
institutional rules.
• At the University of Tennessee Health Science Center in, biosafety
staff concluded in a 2013 report that the root causes of a researcher
failing to get her experiments approved included "general indifference of
the investigator to institutional rules governing the need for biosafety
compliance" as well as a "lack of oversight of research activities." The
scientist, the investigation revealed, knowingly launched unapproved
experiments — exposing mice to a genetically manipulated strain of
Burkholderia thailandensis — in a quest to get a vaccine study manuscript
published that reviewers said needed additional data. 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.
对于不在Select Agent计划中的实验室，甚至是那些实验室，
自我监管是生物安全的前线。的生物安全委员会
通常由科学家同事组成的研究机构评估
拟进行研究并授予或拒绝批准研究的风险。实验室也
还有其他安全人员可以进行内部检查和实验室审核，
加上其他监督动物研究使用的委员会。
然而，一些研究人员对他们机构的生物安全规则一无所知。
其他人则无视生物安全人员的一再停止要求
实验和解决问题。
大学，联邦政府为保持实验室失灵而斗争
美国今日网络获得的文件包括至少50起事件
自2012年以来，研究人员一直在进行转基因研究
未经内部安全部门适当批准而操纵的生物
委员会。在某些情况下，记录显示研究人员自夸他们
制度规则。
•在田纳西大学健康科学中心，生物安全
工作人员在2013年的报告中得出结论，研究人员的根本原因
未能让她的实验获得批准的原因包括“对
研究者研究了管理生物安全需求的机构规则
合规性”以及“缺乏对研究活动的监督”。
调查显示，科学家故意未经批准发射
实验-将小鼠暴露于转基因的
Burkholderia thailandensis —为了获得疫苗研究手稿
发表评论者说需要更多数据。该研究是
兽医发现几只死死的笼子后被捕
小鼠，但没有一个笼子被感染剂标记，它们
在未经批准用于BSL-2病原体实验的地区。的
希拉·尚普林（Sheila Champlin）说
中心副校长指出纠正措施是
在允许科学家继续研究之前拍摄的照片。
//
• At the University of Iowa, a biosafety officer in February 2014
discovered that a scientist had been conducting experiments with a
genetically manipulated strain of the MERS virus since September 2013
without biosafety committee approval. 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. The university concluded that the scientist
did not "effectively communicate" to his staff the importance of getting
safety committee approval before starting the experiments with the virus,
which can cause a deadly, contagious respiratory disease in people.
• At the University of California-Irvine, a researcher ignored
repeated notices from biosafety staff during 2012 and 2013 that a research
project's approval had expired, that it needed further revisions and that
all work must cease — yet the scientist continued the experiments with a
lentivirus, anyway, in the BSL-2 lab. As a result of the incident, the
university now sends researchers four notices starting 90 days before
approvals expire, said James Hicks, the university's associate vice
chancellor of research. As the deadline nears, Hicks is copied on the
notices so he can intervene if necessary. "We take a very strong view and a
very correct view of the importance of following the regulations and the
guidelines," he said in an interview.
• At the University of Nebraska, a biosafety officer in 2013 found
that a researcher had continued growing plants as part of an experiment
using a transgenic tobacco rattle virus vector — despite being told
repeatedly over two months that additional approval was needed from the
biosafety committee before research could begin. As a result of the incident
, the university said it revised its biosafety guidelines to describe
consequences of unapproved research and sent a letter to faculty. "This was
an isolated instance that was fully and successfully resolved," the
university said.
•2014年2月，在爱荷华大学担任生物安全官员
发现一位科学家一直在与
自2013年9月起对MERS病毒进行基因改造
未经生物安全委员会批准。生物安全官员下令
研究人员停止了所有实验，而科学家被处以缓刑
并加强了安全监控。该工作是在BSL中完成的，
当时发现了3个实验室，但从BSL-2实验室开始，
调查人员的调查结果。大学得出结论说，科学家
没有“有效地沟通”给他的员工
安全委员会批准，然后再开始对该病毒进行实验，
可能导致人致命，传染性的呼吸道疾病。
•在加州大学欧文分校，一位研究人员忽略了
生物安全人员在2012年和2013年间多次发出通知，称一项研究
项目的批准已过期，需要进一步修订，并且
所有工作都必须停止，但科学家继续进行了实验，
慢病毒，无论如何，在BSL-2实验室中。由于该事件，
大学现在从90天前开始向研究人员发送四个通知
大学的副校长James Hicks说，批准已经过期
研究大臣。随着最后期限的临近，希克斯（Hicks）被复制到
通知，以便他可以在必要时进行干预。 “我们持非常强烈的看法，
关于遵守法规和法规的重要性的非常正确的看法
准则。”他在接受采访时说。
•内布拉斯加大学的一名生物安全官员在2013年被发现
研究人员在实验中继续种植植物
使用转基因烟草拨浪鼓病毒载体-尽管被告知
在两个多月的时间里，需要再次获得
生物安全委员会才可以开始研究。由于事件
，该大学表示已修订其生物安全指南，以描述
未经批准的研究的后果，并致函教师。 “这是
一个完全且成功解决的孤立实例，”
大学说。
//
• At the University of Hawaii-Manoa, biosafety staff discovered a
scientist was doing a type of cancer research in 2012 despite being denied
biosafety committee approval and being repeatedly told not to do the
experiments. Separately, at a March 2013 biosafety committee meeting at the
university, members discussed the need for penalties when researchers fail
to comply with biosafety rules, stating "there must be some consequence and
corrective action other than an email" to the scientist, the minutes say.
Labs that receive funding from the National Institutes of Health and some
other federal agencies are required to report incidents to the NIH involving
certain types of genetically engineered organisms and recombinant DNA
technology. From 2010 through 2014, the NIH received 644 reports of lab
incidents during this kind of research.
Most of the reports the NIH receives are for what it says are non-serious
incidents, such as small spills, splashes, cuts and equipment failures.
Failure to obtain required biosafety committee approvals to do this type of
research are among the more common types of non-compliance.
Although it is not a regulatory agency, the NIH said in a statement that
agency staff have made site visits to 100 institutions in recent years in an
effort to help improve biosafety committee resources and adherence to the
NIH Guidelines for operating their labs.
"Most instances of non-compliance result from a lack of full understanding
of the requirements of the NIH Guidelines, rather than willful disregard,
and our emphasis has been on corrective actions through education, which
institutions seem uniformly responsive to," the NIH said.
Beth Willis is chairwoman of the Containment Lab Community Advisory
Committee in Frederick, Md., home to one of the nation's largest high-
containment research campuses at the Army's Fort Detrick.
•在夏威夷马诺阿大学，生物安全人员发现了
尽管遭到拒绝，但这位科学家在2012年仍在进行某种癌症研究
生物安全委员会批准并一再被告知不要这样做
实验。另外，在2013年3月的生物安全委员会会议上，
大学里，成员们讨论了研究人员失败时的处罚必要性
为了遵守生物安全规则，声明“必须有一些后果，
会议纪要说，除了给科学家的电子邮件以外，还可以采取纠正措施。
实验室获得了美国国立卫生研究院和一些国家的资助
其他联邦机构也必须向NIH报告涉及以下事件的事件：
某些类型的基因工程生物和重组DNA
技术。从2010年到2014年，NIH收到644个实验室报告
这种研究过程中发生的事件。
美国国立卫生研究院收到的大多数报告都是非严肃的
小泄漏，飞溅，割伤和设备故障等事故。
未能获得进行此类安全检查所需的生物安全委员会批准
研究是不合规的较常见类型。
尽管不是监管机构，但美国国立卫生研究院在声明中表示
代理商人员最近几年对100家机构进行了实地考察。
努力帮助改善生物安全委员会的资源并遵守
NIH实验室操作指南。
“大多数不遵守规定的情况是由于缺乏充分的了解
NIH指南的要求，而不是故意无视，
我们的重点是通过教育采取纠正措施，
机构似乎对此反应一致。”
贝丝·威利斯（Beth Willis）是遏制实验室社区咨询的主席
马里兰州弗雷德里克（Frederick）的委员会，是全美最大的高校之一
陆军要塞堡的遏制研究园区。
//
Beth Willis is chairwoman of the Containment Lab Community Advisory
Committee in Frederick, Md., home to one of the nation's largest high-
containment research campuses at the Army's Fort Detrick.
(Photo: Jack Gruber, USA TODAY)
In September 2014, the NIH contacted the University of Louisville after a
whistle-blower alleged the university had knowingly failed to report lab
incidents as required, according to records obtained under the federal
Freedom of Information Act. In response, the university told the NIH that it
discovered three incidents that were not reported to the NIH but should
have been, the records show.
The records indicate that University of Louisville biosafety officials were
aware of some of the unreported incidents as much as six months before the
NIH opened its inquiry. William Pierce Jr., the university's executive vice
president for research and innovation, in a statement to USA TODAY, said "
there was apparent confusion regarding the authority and responsibility for
reporting violations to the NIH." Pierce said the university has hired an
outside firm to oversee its biosafety committee and created training courses
for scientists. "We feel confident the current system is working," he said.
The NIH closed its inquiry after the university answered the agency's
questions, filed reports on the previously unreported incidents and agreed
to take actions to ensure better reporting in the future.
"In investigating the incident, we did not find any evidence of willful non-
compliance," the NIH said in response to USA TODAY's questions.
For some residents living near labs, the lack of transparency is frustrating
— and worrisome. It's not enough to tell the public the labs have robust
safety procedures. "What people are really interested in is how well it's
working," said Beth Willis, the citizen lab safety representative near Fort
Detrick. "The more people in the community feel that there's secrecy, the
more they're distrustful, whether their distrust is warranted or not."
贝丝·威利斯（Beth Willis）是遏制实验室社区咨询的主席
马里兰州弗雷德里克（Frederick）的委员会，该委员会是美国最大的高校之一
陆军要塞堡的遏制研究园区。
（照片：杰克·格鲁伯，今日美国）
在2014年9月，NIH与路易斯维尔大学联系后，
举报人指控该大学明知没有报告实验室
根据联邦获得的记录，按要求进行事故
信息自由法。作为回应，该大学告诉美国国立卫生研究院
发现了三起事件，这些事件没有报告给NIH，但是应该
记录显示。
记录表明，路易斯维尔大学的生物安全官员是
大约在事件发生六个月之前就知道了一些未报告的事件
美国国立卫生研究院开始其调查。小威廉·皮尔斯（William Pierce），该大学的执行
副总裁
研究与创新总裁在今日美国的一份声明中说：
关于授权和责任存在明显的困惑
向国立卫生研究院报告违规行为。”皮尔斯说，大学已经雇用了一名
外部公司监督其生物安全委员会并创建了培训课程
对于科学家。他说：“我们对当前的系统正在运行充满信心。”
在大学回答了该机构的要求后，NIH结束了调查
问题，提交关于先前未报告事件的报告并获得同意
采取行动以确保将来有更好的报告。
“在调查事件时，我们没有发现任何故意的非证据，
NIH回应《今日美国》的问题。
对于住在实验室附近的一些居民而言，缺乏透明度令人沮丧
-令人担忧。仅仅告诉公众实验室还不够强大
安全程序。 “人们真正感兴趣的是它的状况如何
工作”，堡垒附近的市民实验室安全代表Beth Willis说
德里克“社区中越来越多的人感到秘密，
不管他们是否不信任，他们都不信任。” |
|
