Thank you for your letter and questions regarding the Watertown Biosafety Committee (WBSC). I consult for the Watertown Board of Health/WBSC, serve as the designee by the director of Public Health and would like to clarify some of the points you raised and answer your questions.
The Biotechnology regulations were enacted to protect Watertown residents by mandating companies performing specific types of work to meet certain requirements. These regulations were developed based on regulations from surrounding communities, but in some aspects are stricter than some of our neighboring communities. For example, Watertown requires a permit for companies performing most work under Biosafety level 2 (BSL2) regardless of whether the work involves synthetic or recombinant DNA (rDNA) which is not true of all municipalities in the greater Boston area. Additionally, Biosafety level 4 (BSL4) work such as what is done at NEIDL is not permitted in Watertown. BSL4 work includes research on materials that could easily be transmitted in the air within the laboratory and cause severe to fatal disease in humans for which there are no available vaccines or treatments (eg Ebola virus, Monkeypox virus).
Part of the permitting process involves mandating that companies form an institutional biosafety committee, known as an IBC. The IBC is based on what is required by the NIH for research with rDNA and must include a member that can represent community interests (the community member). It is a requirement that the community member (not a sponsor) works in Watertown or lives in a neighborhood abutting Watertown (hence West Cambridge, not East Cambridge qualifies).
The primary role of the IBC is to review the work (protocols) and approve procedures to ensure the work is conducted safely. This includes discussion of training requirements for staff, required personal protective equipment (eg lab coat, gloves, safety goggles), work equipment (eg a biosafety cabinet, centrifuges with capped rotors) required for work with various organisms as well as the inactivation and disinfection practices required before disposal. While the WBSC does not participate on the IBC to directly instruct on a particular safety process, we do review the minutes of IBC meetings and require companies to conduct them annually. Based on IBC meeting minutes submitted to us, the WBSC has confidence that no “toxic or diseased products” are sitting in public areas because we are aware of what concentrations of bleach or other disinfectants are used to decontaminate all materials before they are taken to common areas for disposal.
The Watertown regulation also requires all companies to submit manuals for their Emergency Action Plan, Biosafety Plan and Chemical Hygiene Plan and these are reviewed by the WBSC as part of the permitting process. Many companies utilize safety consultant companies to help develop their safety plans and yes, sometimes they forget to update various aspects of their safety plans when they move from Cambridge to Watertown. That being said, the ability of the WBSC committee members to identify where updates were missed (in 150+ page safety manuals) highlights how detail-oriented committee members are in ensuring that these documents are updated and appropriate prior to work being conducted in Watertown.
As to your question about whether we are gatekeepers or coaches, the committee is here to ensure that work is going to be conducted safely and follow the Watertown biosafety regulations. There are multiple instances where companies have submitted applications for a “low-risk” registration and the WBSC has required resubmission for the work under a permit. In most instances these conversations happen before the WBSC meeting in order to facilitate a streamlined approval process. As a reminder, decisions about where laboratory spaces are permitted in Watertown is outside the purview of the WBSC and is handled by the zoning board.
In addition to the documents mentioned earlier, the WBSC requires multiple materials to be submitted for a permit, including a detailed list of all agents/organisms used with their biosafety levels, an occupational health contract for all company employees, liability insurance to protect the City of Watertown, a pest control contract, floor plans, security information, safety training and frequency and more.
We encourage all members of the public to attend WBSC meetings and strive for an open and transparent process. Additionally, my email is available on the WBSC website and I am happy to answer additional questions about the permitting/registration process.
Mia Lieberman, DVM, PhD, DACLAM
Watertown Biosafety Committee Consultant