In my April 16th 2020 blog, I wrote about the new Watertown regulation Biotechnology and the Use of Recombinant DNA Molecule Technology which became effective July 1, 2020. Existing facilities located in Watertown will have one year from the effective date to come into compliance, but new companies moving to Watertown must comply before work covered by the regulation can begin.
The regulation covers recombinant DNA (rDNA) work as well as non-rDNA research involving biologic agents at Biosafety Level 2 (BSL-2) and Biosafety Level 3 (BSL-3). (BSL-4 work is prohibited in Watertown.) Examples of agents at BSL-2 include non-recombinant work with Salmonella enterica, Staphylococcus aureus, Hepatitis B, and Herpes Simplex Virus.
Non-exempt rDNA work and work with regulated biologic agents requires a permit. However, low risk facilities may conduct rDNA work without a permit provided that they register with the Watertown Biosafety Committee (WBSC). A low risk facility is one that creates, propagates, imports or uses rDNA in any form where:
- The experiments are all exempt from the NIH Guidelines under Section III-F; or
- Users are not constructing rDNA organisms but are merely propagating them.
For companies that do require a permit, the application process is quite involved and includes submitting an application with supporting documentation (described in my previous blog,) to the Watertown Biosafety Committee (WBSC), and a presentation to the Watertown Board of Health (BOH) after the WBSC reviews the application. BOH meetings are currently being held remotely (Zoom) on the third Wednesday of every month at 7 pm. At this time, the WBSC is not conducting walkthroughs due to COVID.
I wanted to pass along some tips that we have learned from assisting our Watertown clients to hopefully make the process easier for others.
- The estimated time between submission of the application and the completion of the application review by the WBSC is currently 60 days. Regulated work cannot begin during the review process. However, a low risk registration can be submitted so that BL1 work can start as the permit application is reviewed and approved.
- The 60-day estimate does not include the BOH presentation or addressing any post- BOH meeting questions from the WBSC. It may take up to an additional month for final permit approval which gets announced at the next BOH meeting.
- In order to expedite the application review process as much as possible, the WBSC recommends organizing the application supporting information in such a way that facilitates review. Tabs that separate the various sections is one suggestion that was made. The more complete and organized the application is, the faster it will be processed! It will slow things down if the WBSC has to come back for additional information/clarification. Six copies of the application and supporting materials should be submitted.
- One of the supporting documents required is a plot plan showing the proposed location of the facility and a floor plan showing the layout. The WBSC has requested that the plot plan include elevations.
- The initial Institutional Biosafety Committee (IBC) meeting can be held before or during the WBSC application review period. The minutes should be provided to the WBSC if they are not included with the application.
- One to two weeks after the BOH meeting, the WBSC will convene to discuss approval of the permit application. Following the meeting, the Director of the BOH will contact the company’s point of contact to notify them of the WBSC’s decision and request additional information (if applicable). (Note that the BOH wants companies to identify one person within the company to be the point of contact.)
- The WBSC can request additional information, such as any safety-related documents or procedures that were mentioned during the BOH meeting presentation, or recorded in the IBC minutes, if they were not included in the initial application. Examples include BL2+ spill procedures, or Standard Operating Procedures (SOPs). When additional information is requested, it generally has to be submitted within one week.
For more information on the new Watertown regulation, or for assistance with obtaining your permit, please email [email protected].
This blog was written by Beth Graham, our Associate Director of Quality, Research, and Training who has been with Safety Partners Inc. for the last 11 years.