Can anybody set up a Level 3 biolab? Is permission necessary?

[Milossarian]

I ask because a local vector control district (a taxpayer funded agency that thinks it’s more important than it actually is, but that’s really just glorified mosquito exterminators) is saving money to build a Level III bio-lab.

We learn here that bio-safety Level 3:

This level is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease after inhalation. It includes various bacteria and viruses that can cause severe to fatal disease in humans, but for which vaccines or other treatment exist, such as Mycobacterium tuberculosis, Bacillus anthracis, West Nile virus, Venezuelan equine encephalitis virus, Eastern equine encephalitis virus, Hendra virus, SARS coronavirus, Salmonella typhi, Coxiella burnetii, Rift Valley fever virus, Rickettsia rickettsii, and yellow fever virus.

I know that the guidelines and protocols for the various bio-safety levels are set by the CDC.

Perhaps I’m missing it, but nowhere do I see a permitting process, whereby the CDC or anybody else evaluates a proposed Level 3 facility, and gives it a thumbs-up or a thumbs-down. Indeed, that CDC link uses the word “recommended” a lot.

The number of different levels on which this Level III bio-lab that’s proposed is stupid are numerous – populated area, within a block of one of the most heavily used freeways and railway corridors in the country, within 5 miles from a very dangerous section of the San Andreas fault that’s overdue for a major earthquake.

I’m trying to figure out if there’s some regulatory authority that would say, “No, you goobers don’t get to decide this is a good idea on your own. It’s a bad idea, and it’s not happening.”

[yoyodyne]

@Milossarian

I’m trying to figure out if there’s some regulatory authority that would say, “No, you goobers don’t get to decide this is a good idea on your own. It’s a bad idea, and it’s not happening.”

There are at the State level. What State is it in?

[Pray_for_peace]

There are mandatory federal certification procedures, in most cases (there are exemptions), for laboratories that will be working with organisms or toxins deemed “select agents or toxins” by the CDC and APHIS (part of USDA).

Unless exempted under § 73.5, an individual or entity shall not possess, use, or transfer any HHS select agent or toxin without a certificate of registration issued by the HHS Secretary. Unless exempted under § 73.6 or 9 CFR part 121.6, an individual or entity shall not possess, use, or transfer overlap select agents or toxins, without a certificate of registration issued by the HHS Secretary and Administrator.

CDC Select Agent Regulations. (PDF)

Link to other Select Agent Regulations. (PDF)

There may be other federal requirements for BSL-3 labs working with organisms that are not “select agents” (try searching for “BSL3” or “BSL-3”).

[Pray_for_peace]

Here are some additional resources on U.S. federal regulation of BSL-3 laboratories.

On September 22, 2009, the House Energy and Commerce Committee held a hearing on federal oversight of high containment bio-laboratories (BSL-3 and BSL-4). Several relevant quotes from the preliminary transcript (PDF) of the hearing follow:

…Unfortunately, many problems still exist such as no single
agency or office in the Federal Government keeps track of how many
high‐containment labs there are in the United States, where they
are located, what types of research they are doing and whether
they are safe and secure. In short, there still appears to be no
adequate Federal plan or effort to manage, much less coordinate,
highly dangerous research. There are no universal standards for
lab design, construction, or use.

The Department of Health and Human Services publishes a
guideline, Biosafety in the Biomedical and Microbiological
Laboratories, known as the BMBL. Labs that receive NIH grants
must comply with BMBL guidelines, but private and other
nonfederally funded facilities have no similar requirement. While
labs that handle select agents must obtain Federal registration
and certification, no accreditation or certification is required
for labs working with dangerous organisms that are not on the
select agent list, such as SARS or West Nile Virus.
…(p. 4)

…
Mr. Walden. [edit: R-Ore.] If I wanted to go out and build a lab and deal with these agents at Level 3 or 4, can I do that and not tell anybody?
Ms. Kingsbury. [edit: witness; Managing Director, Applied Research and Methods, GAO] You can’t do it and not tell anybody if they are on the select agent list.
If they are not on the select agent list, then, yes, you can. All you have to do is get the money for it.
(p. 38)

Here is a July 2009 report prepared by a HHS/USDA task force, the Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight (PDF). It includes a historical overview of federal oversight of biosafety/biocontainment; an overview of U.S. federal regulatory framework (e.g., “Select Agent” regulations, applicable OSHA regulations, CDC import regulations, etc.); examples of state and municipal oversight of biosafety/biocontainment (approx. pp. 60-63); and policy recommendations. It also contains a definition that might be helpful in researching applicable state or municipal laws or regulations:

“High and maximum containment” is the term used in this report to describe BSL-3 and
BSL-4 laboratories and equivalent containment facilities, i.e., animal facility/vivarium
ABSL-3 and ABSL-4, and biosafety level-3 agriculture (BSL-3-Ag) facilities. More
specifically, “high containment” refers to BSL-3 and equivalent containment facilities,
whereas “maximum containment” refers to BSL-4 and equivalent containment facilities.
The research activities that occur in high and maximum containment facilities include
studies of hazardous pathogens that infect humans, zoonotic agents, toxins, and a range of
agricultural pathogens, which include foreign and emerging agricultural agents that can
infect livestock and crops. (For definitions of additional terms used in this report, see the
Glossary.) (p. 16)

Another document with potentially relevant background is the Congressional Research Service Report for Congress re: High-Containment Biological Laboratories (May 4, 2009) (PDF)

[KarlGrenze]

@Milossarian

The number of different levels on which this Level III bio-lab that’s proposed is stupid are numerous – populated area, within a block of one of the most heavily used freeways and railway corridors in the country, within 5 miles from a very dangerous section of the San Andreas fault that’s overdue for a major earthquake.

I’m trying to figure out if there’s some regulatory authority that would say, “No, you goobers don’t get to decide this is a good idea on your own. It’s a bad idea, and it’s not happening.”

All the regulatory cites I leave to someone else (who has provided them), but I just wanted to let you know that you’d be surprised how many BSL-3 labs are around.

For example, wouldn’t surprise me the least if the CDC headquarters in Atlanta itself has a couple of labs.

Most major research facilities (universities) have at least one, if not more.

Depending on how mosquito and tick infested your area is, it would make sense to have a lab capable of dealing with West Nile Virus, Easter Equine Encephalitis virus, and Ricketsia ricketsii (Rocky Mountain Spotted Fever). All those would require, per the cites provided, a BSL-3 lab.

That said, I do know the BSL-3 labs around my work are subject to much scrutiny and monitoring.

[IvoryTowerDenizen]

I have a BL2 lab that required State authorization and a once every year inspection by DPH to maintain certification. I imagine BL3 would require at least that.

[Harmonix]

@KarlGrenze

All the regulatory cites I leave to someone else (who has provided them), but I just wanted to let you know that you’d be surprised how many BSL-3 labs are around.

For example, wouldn’t surprise me the least if the CDC headquarters in Atlanta itself has a couple of labs.

Actually the CDC headquarters in Atlanta has one of the few biosafety level FOUR labs in the country. That place houses the nasty stuff. There has never been an accidental release of a pathogen from a BSL-4 lab.

A BSL-3 lab has nothing to worry about. We’re not really talking pandemic if something accidentally gets out.

[cerberus]

Both CDC and USAMRIID have BSL-4 labs.

[Pray_for_peace]

There are also BSL-4 labs at the University of Texas Galveston (Galveston National Laboratory), Georgia State University, and the Southwest Research Institute in San Antonio, Texas. Another BSL-4 lab is under construction at Boston University Medical School.

[KarlGrenze]

UGA has a BSL-3AG, which is the equivalent to BSL-4 for animal diseases. Few others BSL-3 labs are maintained by UGA and the research facilities around Athens.

[Pray_for_peace]

Quote from a 2005 survey (cite):

In total, 598 individual laboratories are associated with the 245 facilities that report BSL-3 capabilities. Responses indicated that there are nine or more facilities having BSL-3 capability in eight states (California, Washington, Wisconsin, Pennsylvania, New York, Connecticut, Tennessee, and Florida), while another three states (Texas, Maryland, and Indiana) have between seven or eight facilities with that capability. Most facilities with BSL-3 capability have three or fewer laboratories, although one institution reported having 30 such labs.

List of NIAID-funded Regional Biocontainment Laboratories (BSL-3)
Certification of BSL-3/”Select Agent” Lab at Lawrence Livermore National Labs

[mozchron]

Wow. I have been lurking for almost 10 years, and this is the post that made me sign up.

I can actually directly address the OP’s concerns - I am a University professor who has worked with BSL2 and BSL3 arthropod-transmitted pathogens for over 10 years. The first thing to realize is that BSL3 labs are very common – any medical school or even decent University microbiology department will have the capability to work under level 3 conditions. The things in these level 3 labs are not THAT nasty – the increased biosafety level is to protect the workers, not really to protect the public. In most cases, the pathogens they are working with are circulating in the wild, maybe in your backyard.

Your vector control district almost certainly wants a level 3 lab to do their own West Nile virus (WNV) isolations. It is barely possible that they also want the ability to work with chikengunya virus (CHIK isn’t here yet but it probably will be within the next 5-10 years, and will make WNV look like nothing). If they are working with WNV, I, as a resident, wouldn’t worry at all – you have orders of magnitude greater chance of being exposed by mosquito bite in your own back yard. In fact, chances are pretty good that you have already been infected and never knew it.

Now, whether your local vector control district SHOULD have a level 3 lab is a different question. Some states have very well qualified mosquito abatement and vector control programs (California and New Jersey come to mind) – in these states, SOME districts have significant research programs and have PhD-level scientists (including virologists) on staff. Does yours? I don’t know.

If the level 3 lab isn’t working on Select Agent pathogens (WNV is not a select agent) then the certification is easier (you need CDC and sometimes USDA certification). The paperwork in a bit of a bitch, but it always is. If select agents are being worked on (or even just housed there) then you get into much more detailed Federal oversight including FBI background checks, security clearances etc…

The hairy stuff is Biosafety level 4. There are only a few BSL4 labs in the country. Very few people are rated and certified to work in BSL4 conditions. I am not BSL4 certified, and have no intention of ever doing it, but am familiar with how they are designed. I have also had the unique privilege of touring a BSL4 lab that was not “hot” – and I needed to pass a criminal background check just to get into the building lobby.

Without saying too much, I can tell you that there has never been a release of an agent from a BSL4 lab. Because of the way they are designed, coupled with the safety procedures, training and background checks under which they run, I will say it is effectively impossible for an agent to be accidentally or even deliberately released.

So don’t worry about your local BSL3 lab.