united-states research enforcement
Who decides if a microbiology lab is BSL-2 compliant in the US?
<p>I am currently searching for a <a href="https://www.cdc.gov/cpr/infographics/biosafety.htm" rel="noreferrer">BSL-2</a> lab for a microbiology project that I am starting, which lead me to a rather basic question:</p>
<p>I understand that in the US, the CDC defines what each biosafety level entails, but do they also certify/keep track of the labs that are BSL-2? Or is it certified by third parties? Could any company rent a space and make it into a BSL-2 lab given that they outfit it with the required safety equipment etc?</p>
<p>Another way of asking the questions is, how are the CDC's guidelines enforced?</p>

<p>There are no legal requirements for official certification of BSL-1 and BSL-2 laboratories in the US. There are <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-F/part-73?toc=1" rel="noreferrer">legal requirements</a> for higher-level labs that deal with Select Agents. The CDC has a <a href="https://www.cdc.gov/clia/law-regulations.html" rel="noreferrer">page on certification laws and regulations</a>, which is &quot;about&quot; samples derived from the human body. Organizations (such as universities) have offices that perform inspections and approve (or not) a particular laboratory, by reference to standard professional guidelines. This is, of course, different from the situation in Europe. There may be state-level legal requirements.</p>

<blockquote>
<p><sup><a href="https://www.phe.gov/s3/BioriskManagement/biosafety/Pages/Biosafety-FAQ.aspx#over14" rel="nofollow noreferrer">1</a></sup>The Federal entities that have primary regulatory oversight responsibility for organizations that possess, use, or transfer infectious agents, toxins, or other biological hazards are:</p>
<ul>
<li>Department of Labor (DOL), Occupational Safety and Health Administration (OSHA)</li>
<li>Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC) and National Institute for Health (NIH)</li>
<li>U.S. Department of Agriculture, Animal and Plant Health Inspection Service (APHIS)</li>
<li>U.S. Department of Transportation (DOT)</li>
<li>U.S. Department of Commerce (DOC)</li>
</ul>
</blockquote>
<p>Oversight of BSL facilities depends on the types of organisms and activities within the lab. Most research universities have BSL-2 facilities, and those are usually immediately overseen by the university's own environmental health department.</p>
<p>Although mostly involving BSL-3 and BSL-4 facilities, some BSL-2 facilities <a href="https://www.gao.gov/assets/gao-18-145.pdf" rel="nofollow noreferrer">are registered</a> with the US <a href="https://www.selectagents.gov/" rel="nofollow noreferrer">Select Agent Program</a>, which oversees possession and use of agents and toxins &quot;which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products.&quot;</p>
<blockquote>
<p>The CDC is responsible for the registration and oversight of laboratories that possess, use, or transfer select agents and toxins that could pose a threat to human health. USDA is responsible for the registration and oversight of laboratories that possess, use, or transfer select agents and toxins that could pose a threat to animal or plant health or animal or plant products. Some select agents, such as anthrax, pose a threat to both human and animal health and are regulated by both agencies.<sup><a href="http://www.gao.gov/pdf/product/117997" rel="nofollow noreferrer">2</a></sup></p>
</blockquote>

<h1>Certification is required</h1>
<p>Incidentally, the BSL levels are not just national, they are almost the same internationally, as they have been developed by international committees for disease control. The only difference between countries is generally the certification process and if you have a private or public certification body, but not what it requires.</p>
<p>BSL laboratories almost always need certification from some institution that checks that they actually follow the regulations before starting work. Pubmed has articles about <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5819027/" rel="nofollow noreferrer">common issues and the certification process in <strong>India</strong></a>. Biomedical Science Letters describes the BSL2 Audit process and requirements <a href="https://www.bslonline.org/journal/view.html?doi=10.15616/BSL.2016.22.3.65" rel="nofollow noreferrer">for a <strong>Singaporean</strong> lab.</a></p>
<p>Universities typically already have the lab certifications and strict rundowns on how to get into those. A typical rundown of how to access to a BSL-2 lab can be found in the <a href="https://www.safety.rochester.edu/labbiosafe/bsl2certification.html" rel="nofollow noreferrer">Rochester University guidelines</a>, which is located in New York. <a href="https://www.cmu.edu/ehs/Laboratory-Safety/biological-safety/documents/requirements-for-laboratories-under-biosafety-level-23.pdf" rel="nofollow noreferrer">Carnagie Mellon University</a> in Pennsylvania has similar rules.  <a href="https://uwm.edu/ibc/bsl2_requirements/" rel="nofollow noreferrer">The university of Wisconsin/Milwaukee</a> offers the guidelines for BSL2 as well.</p>
<h2>Certification is not just for the lab... but for each item in it!</h2>
<p>The CDC also has a whole book on the matter. <a href="https://www.cdc.gov/labs/pdf/CDC-BiosafetymicrobiologicalBiomedicalLaboratories-2009-P.pdf" rel="nofollow noreferrer">2009 saw the 5th edition</a>, <a href="https://www.cdc.gov/labs/pdf/CDC-BiosafetyMicrobiologicalBiomedicalLaboratories-2020-P.pdf" rel="nofollow noreferrer">2020 the 6th</a>. These books also contain specific certification requirements to keep the overall BSL level certification for the lab. For example, a random item I picked is the &quot;Biological Safety Cabinet&quot;.</p>
<blockquote>
<p>D. Laboratory Facilities (Secondary Barriers)</p>
<ol start="10">
<li>BSCs and other primary containment barrier systems are installed and
operated in a manner to ensure their effectiveness. See Appendix A.</li>
</ol>
<p>c. BSCs are certified at least annually to ensure correct performance,
or as specified in Appendix A, Part 7.</p>
</blockquote>
<blockquote>
<p>The evolution of containment equipment for varied research and diagnostic
applications created the need for consistency in construction and performance.
Federal Standard 20929 was developed to establish classes of air cleanliness and
methods for monitoring clean workstations and cleanrooms where HEPA filters
are used to control airborne particulates. It has since been replaced with <strong>ISO
14644-2015</strong></p>
</blockquote>
<p>So the BSC has to comply with <a href="https://www.iso.org/standard/53394.html" rel="nofollow noreferrer">this standard</a> - and as you notice, the standard costs a couple hundred swiss francs and is only to get the <em>specifications</em> of the <em>one</em> item. Yes, lab certification is <em>expensive</em>, as you need to certify a lot of items to get the overall safety certification from the relevant certification agency.</p>
