USAMRIID (copy)

The U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick.

It is not unusual for the Centers for Disease Control and Prevention to inspect a laboratory at Fort Detrick.

Expected or unannounced inspections by the CDC are just part of the regulations the U.S. Army Medical Research Institute of Infectious Diseases adheres to so that it can study dangerous viruses, toxins and bacteria.

The fact that the CDC found problems in its latest inspections of the facility illustrates why such regulations are needed, many have said.

For many other laboratories across the country, including in Frederick, such regulations do not exist, said Craig Reed, a biosafety expert and CEO of Inspirion Biosciences, a company that helps organizations manage the risk involved with biological materials or disease-causing material.

USAMRIID received a cease and desist order July 15 to research in its biosafety level 3 and 4 laboratories, following a June inspection by the CDC. USAMRIID also lost its registration in the Federal Select Agent Program, which allowed scientists to study viruses and bacteria such as Ebola or Venezuelan equine encephalitis.

USAMRIID is one of the heavily regulated laboratories, said Reed, who also spent several years there as a bacteriologist.

Because USAMRIID is part of the Federal Select Agent Program and the Army, it is inspected by the CDC, the U.S. Department of Agriculture and the Department of Defense. Under the Code of Federal Regulations, those in the FSAP program can be inspected by the CDC during announced and unexpected visits.

That’s more regulations than apply to many of the private or academic containment laboratories that do not fall under the Federal Select Agent Program, Reed said. The biosafety level does not refer to the danger of a pathogen, or disease-causing material, but rather the system required to contain it.

A biosafety level 1 laboratory is what most high school science laboratories are. Biosafety level 2 labs require gloves and lab coats, with face masks sometimes used. Biosafety level 3 brings stronger personal protective equipment, including face masks. When a person enters a biosafety 4 laboratory, they wear suits similar to hazmat ones with air pumped into the suit.

The higher the risk of a pathogen and less ability to treat it, the more containment it will need. So Ebola is studied in biosafety level 4 laboratories because until recently very little treatment was available to those infected. With biosafety level 3 laboratories, there are some agents, such as Yersinia pestis, the bacterium that causes the plague, fall under the Federal Select Agent Program. Others, including tuberculosis, are studied in biosafety level 3 laboratories but are not part of the program, Reed said.

To Reed, there are five problems with biosafety level 2, 3 and 4 labs in general, mostly in the private sector or academia. The first is the rules and the lack of enforcement of them.

The U.S. guidelines for containment labs are in “Biosafety in Microbiological Biomedical Laboratories,” which is in its fifth edition. The 438-page manual can be downloaded from the CDC website, but it is complicated. Those who do not study biosafety would have a hard time understanding it, Reed said. But they are voluntary compliance guidelines. 

“Unfortunately, aside from the Select Agent Program laboratories, there is no routine or uniform process to validate implementation of these guidelines and there is no consistent mechanism of corrective action for identified shortcomings," Reed said in an email. "Therefore, for the majority of BSL-2 and BSL-3 laboratories in the US, we simply aren’t certain they’re operating according to the best practices guidelines found in the ["Biosafety in Microbiological Biomedical Laboratories"] and there are few documented penalties that I’m aware of for those that don’t.”

The second problem is an absence of public reporting and transparency, especially with smaller organizations, he said. Although USAMRIID did inform the public about its cease and desist letter, it was up to the laboratory to do so. The CDC does not comment on those in the FSAP program or actions taken to regulate them, according to previous News-Post reporting.

“What’s the secret? I mean honestly, what’s the secret? Why shouldn’t we know?” Reed said.

The third and fourth problem is a lack of credentialed biosafety professionals and education in biosafety, he said. The final problem is that there is no system for communication or control between the different agencies, including state agencies and local agencies when a biosafety failure occurs.

On the local level, Reed said, the question becomes what local officials know about biosafety regulation and what they know about which companies have biosafety level 2 or biosafety level 3 laboratories that do not fall under the Federal Select Agent Program. This is especially true for companies that have biosafety as just another assignment, he said.

“It’s the ones lurking under the surface that are the biggest problem,” he said. “And I worry about that for the city of Frederick and the people of Frederick.”

Changes on a local level

Del. Karen Lewis Young (D-Frederick) has spent several years trying to get a registry of biosafety 3 laboratories. For the past couple of years, she submitted legislation that would require those labs to register with the Maryland Department of Health so that public health officials, emergency management and law enforcement would be able to respond in an emergency.

“We have no idea how many there are throughout the state, where they are,” Lewis Young said.

The legislation has passed the Maryland House of Delegates three times but was killed in the Maryland Senate each time, she said.

There are a fair number of the labs in the county, she said, which Reed echoed. Private labs tend to cluster around public ones, so Fort Detrick would draw them in, she said.

But Lewis Young could not tell a person where the labs are. There needs to be some oversight, she said.

This year, she thought the law would pass. Now, she is unsure whether she’ll bring it back up again. She said she can submit an item only so many times before turning her attention to other legislative needs.

“Maybe this recent issue will help prioritize it,” she said.

County Executive Jan Gardner was told about the cease and desist letter, she previously told The Frederick News-Post. Any press conferences or public release of the information needed to come from USAMRIID, she said.

“My approach has always been to tell everything that happens and do it in one fell swoop, and then tell people what you are going to do to prevent it in the future, what you’re doing to react and what you’re going to do to prevent it in the future,” Gardner said.

Gardner said she is not a scientist, and it would not be fair for her to try to explain what was happening at USAMRIID to the public. She relies on her public health officials to provide her with timely, complete information. She plans to meet with Fort Detrick officials in the future about the USAMRIID issues, she said.

“We need to make sure we’re informed,” Gardner said.

It is her understanding that Jack Markey, director of emergency management in Frederick County, knows where the biosafety level 3 laboratories are. She does not think that regulation would fall to the county government. According to the city of Frederick’s website, there are two biosafety containment labs outside of Fort Detrick.

“The bigger question to my mind ... was that we need to make sure, and the public has the right to know, that levels of government — it may not be county government, but levels of government are making sure that public health and welfare is always protected,” she said. “And citizens have a right to know if there are issues, what risk is there and what steps are being taken.”

Follow Heather Mongilio on Twitter: @HMongilio.

Heather Mongilio is the health and Fort Detrick reporter for the Frederick News-Post. She can be reached at hmongilio@newspost.com.

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