Understanding
Biosafety Levels
(BSL)
Melanie Cohn, Sr. Director, Regional Policy and Government Affairs September 26, 2023 | Belmont City Council Meeting
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Biocom supports the building of additional units to house California’s ever-growing life science workforce. Housing Biocom supports balanced regional transportation plans
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Local taxes and fees can have detrimental effects on the development and production of new treatments. We advocate for measures to be predictable, equitable, transparent, and stable. It is especially important that similar businesses have similar tax burdens.
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& Fees
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manufacturing, R&D, and distribution. We also encourage local governments to identify and incentivize physical areas for life science establishments where appropriate.
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Biocom supports efforts to make city and county permitting processes predictable, transparent and efficient. Permitting 8 Biosafety Levels:
What are they?
Biosafety levels (BSL) outline safeguards
designed to protect lab personnel, as
well as the surrounding environment
and community.
There are four biosafety levels, each
with its own specific controls that are
required for lab practices, safety
equipment, and facility construction.
How do control
environments compare?
The BSL categories are divided up by risk of
disease combined with availability of
preventative and therapeutic treatments. BSL-1
labs have surfaces that are easy to clean. BSL-2
require lab coats and glasses, have hand and
eye washing stations, automatic closing doors,
and access to decontamination equipment.
BSL-3 lab precautions include (but are not
limited to) extensive PPE, wraparound gowns,
and sustained directional airflow (air cannot be
recirculated). All work done with microbes
occurs in a biosafety cabinet and entrance to
the lab is through two sets of self-closing and
locking doors. Windows and wall surfaces are
sealed.
9 10
Biosafety Levels: Dispelling Myths
There is no such thing as an “unregulated” lab. Every lab, whether public or privately funded, is required to comply with regulations at the federal, state, and local levels.
Comparing criminal clandestine activity such as a lab
operating in a residential garage to regulated lab operations creating treatments and cures for diseases is a false
equivalency. The industry is very highly regulated and has a high rate of compliance because of the staff our companies employ to ensure conformity. In addition to maintaining a multitude of permits, these staff must obtain their own professional certifications in safety and occupational health that require yearly recertification.
11 Who is Regulating?
BSL designation begins with the
design standards. Authorities on
BSL design include: • NIH Design Requirements Manual for Biomedical Laboratories (DRM)
• CDC Biosafety in Microbiological and
Biomedical Laboratories (BMBL)
• NIH Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid
Molecules (NIH Guidelines)
• National Institutes of Health Biosafety
Level 3 Laboratory Certification
Requirements
12 The primary regulatory agency enforcing lab standards in California is Cal/OSHA.
Other regulatory agencies include:
• International Organization for Standardization (ISO) certification • Drug Enforcement Administration license
• US Department of Agriculture registration
• National Institutes of Health registration
• Centers for Disease Control Clinical Laboratory Improvement Amendments (CLIA) certification – regulated by the FDA
• Biosafety Level certification
• Centers for Medicare and Medicaid Services certification • California Department of Public Health licensing and registration • CalEPA Certified Unified Program Agency (CUPA) permit • Hazardous Materials Business Plan compliance
• Medical Waste Management Plan compliance
• Radiological Health (x-ray) permit
• Water, wastewater, and stormwater permits
• Fire department permit
• Air pollution control permit
13 Case study: current Belmont development project
• City of Belmont Planning, Buildings and Public Works Department construction permitting • City of Belmont Industrial Wastewater Permit
• Mid Peninsula Water Permit
• CalEPA/Regional Water Quality Control Board: National Pollutant Discharge Elimination System General Permit • Department of Toxic Substances Control
• Tiered permitting for waste water
• Obtain EPA ID number
• San Mateo County Fire Permit
• San Mateo County Certified Unified Program Agency (CUPA) • California Environmental Reporting System Hazardous Waste Generator Permit • Spill Prevention, Control, and Countermeasure Plan for storage tanks • Hazardous Materials Business Plan
• Medical Waste Registration and Management Plan
• Bay Area Air Quality Management District: emergency generator, authority to construct, Permit to Operate • California Air Resources Board: Cryogenic electron microscopy, Greenhouse Gas reporting • Cal/OSHA
• Proposition 65 compliance and notifications
• US Department of Transportation registration for hazardous materials shipping • Bay Conservation and Development District Permit
14 Lab Regulations continued
The regulations enforced by these agencies are on
the whole very conservative. For example, a lab
cannot pour 12% ethanol down a drain, it must be
disposed of as hazardous waste, meaning that it
never enters the public waste stream. If you poured
a bottle of wine down the drain at your home, under
these same regulations you would be in violation of
your hazardous materials permit.
Would you be willing to buy your morning coffee
next to a Red Cross blood donation center? This is a
BSL-2 lab (maybe BSL-3 depending on the contents
of the donations).
15 What happens in an emergency?
A BSL lab has multiple containments, and
those containments all have backups.
Every lab is required to have an incident
response plan for natural disasters, along
with an emergency response team, in
coordination with the CDC. The lab is isolated
and decommissioned and must be
recommissioned by the FDA.
Thank You.
@Biocom
@BiocomCA