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Home My Public Portal AboutBiotechReg_FAQs_202006161553307416Watertown Biotechnology Regulation FAQ Regulation: Biotechnology and the use of Recombinant DNA Molecule Technology. Ql. What is the intent of this regulation? The regulation requires that all applicable companies within the Town of Watertown adhere to the NIH Guidelines, as well as to the biosafety levels (BSL) and containment measures outlined in the most recent version of Biosafety in Microbiological and Biomedical Laboratories (BMBL). Additionally, the regulation forms a Watertown Biosafety Committee (WBSC) that will review registration and permit applications and make recommendations to the Watertown Board of Health (BOH). Q2. Who makes up the Watertown Biosafety Committee (WBSC)? The WBSC is composed of five members: 1. The Chair of the Board of Health and the Director of Public Health, or their designees. 2. An individual with knowledge and experience in the handling of hazardous materials appointed by the Board of Health in consultation with the Fire Chief, or his designee. 3. Two members of the public with knowledge and experience in biotechnology and are appointed by the Board of Health. Q3. What types of work falls within the purview of this regulation? The regulation covers work that utilizes biologic agents (BSL-2 — BSL-4) and/or work with recombinant DNA (rDNA) technology. The regulation prohibits work requiring BSL-4 containment within the Town of Watertown. Additionally, the regulation allows "Low Risk Facilities" to register with the Town in place of seeking a permit. Q4. Is any laboratory work exempt from the regulation? As stated in Section 7D of the regulation, medical facilities and clinical labs that are using commercially approved, and/or established propriety protocols, for diagnostic testing are exempt. Medical/clinical facilities that collect patient samples for testing at offsite laboratories are also exempt. However, clinical laboratories that are developing new diagnostic testing using rDNA and/or biologic agents must adhere to the regulation. Q5. When will the regulation go into effect? The regulation has an effective date of April 1st, 2020. Companies already performing work within the Town of Watertown will have one year to bring work into compliance, as will companies that have started site -construction before April 1st, 2020. After April 1st, existing companies wishing to make a significant protocol change such as, an increase in the biosafety level, new work with a BSL-3 organism, new work with Select Agents or Toxins as defined by the Federal Select Agent Program, new Large Scale activities as defined in Appendix K of the NIH Guidelines, the addition of work with Lentivirus, and/or the addition of work with Human Gene Transfer are required to seek a permit before the protocol changes can proceed. Completed laboratory spaces, and those under construction, which do not have a leased tenant by April 1st, 2020 will be treated as new entities and will require future tenants to seek registration/permitting before commencing work. April 2020 Page 1 of 4 Watertown Biotechnology Regulation FAQ Q6. How does a company know if it should register vs. apply for a permit? Labs that are BSL-1 and are conducting work that is deemed exempt in Section III -F of the NIH Guidelines, and/or are not creating rDNA containing organisms but merely prorogating them, are deemed to be "Low Risk Facilities" and need only register. Labs that are BSL-2 or above, and/or are conducting non-exempt rDNA work as detailed in the NIH Guidelines must seek a permit. Companies applying for a permit do not need to register. Q7. What is involved in the permitting process? 1. A completed application, with all the required supporting materials, is submitted to the Director of Public Health. 2. A site inspection will be scheduled and carried out. 3. An agent working on behalf of the Board of Health will review the inspection report and application to create a summary for the Watertown Biosafety Committee (WBSC). 4. The applicant seeking a permit will be scheduled to present an overview of the application to the WBSC (sample presentation can be found here). 5. The WBSC will then discuss the permit in question and vote on their recommendation. 6. The applicants' permit will be scheduled for final review at an upcoming Watertown Board of Health (BOH) meeting. 7. The members of the BOH will discuss the WBSC recommendation and vote to issue or deny the permit. Q8. What is the registration process? The registration process is similar to the permitting process, though the requirement for inspection and/or the presentation to the WBSC may be waved. Q9. How long is registration or a permit valid for? Both registration and permits are valid for 1 year. Q10. Are there new activities that would require an amendment to an active registration? If you wish to move to a new location within the Town of Watertown, preform physical expansion of lab space within current facilities, create an additional lab space at another location in the Town of Watertown, and/or to perform Large Scale activities as defined in Appendix K of the NIH Guidelines you must apply for an amendment to the registration before the above - mentioned changes can proceed. Q11. Are there changes that would require a company with an active registration to seek a permit? An increase in containment level above BSL-1, and/or the addition of non-exempt rDNA work as detailed in the NIH Guidelines, requires you to seek a permit prior to the commencement of work. Q12. Are there new activities that would require an amendment to an active permit? If you wish to move to a new location within the Town of Watertown, preform physical expansion of lab space within current facilities, create an additional lab space at another location April 2020 Page 2 of 4 Watertown Biotechnology Regulation FAQ in the Town of Watertown, and/or increase the containment level (BSL) for existing lab space you must first seek an amendment to the permit. Also, a significant change of protocol such as new work with a BSL-3 organism, new work with a Select Agent or Toxin as defined by the Federal Select Agent Program, new Large Scale activities as defined in Appendix K of the NIH Guidelines, the addition of work with Lentivirus, and/or the addition of work with Human Gene Transfer require you seek an amendment to the permit before the change(s) can proceed. Q13. What fees are associated with the regulation? Registration requires an annual fee of $100. Permitting requires an annual fee of $500. Q14. Are there any additional costs to applicants? The Board of Health may retain a professionally competent person, agency or institution to perform inspections and reviews at the permit holder's expense as outlined in Section 8 of the regulation. Q15. What is an Institutional Biosafety Committee (IBC)? An Institutional Biosafety Committee is a committee internal to a company/institution that is responsible for assessing the biosafety containment level for research involving recombinant DNA and synthetic nucleic acid molecules. Their oversight can include, but is not limited to: • Recombinant DNA and synthetic nucleic acid molecules (this includes Human Gene Transfer experiments) • Infectious agents • Biological toxins • Human -derived tissues, fluids, cells • Certain animal -derived tissues, fluids, cells • Federally -regulated Select Agents, experiments with Dual Use Research of Concern potential, and research requiring BSL3 containment The NIH has created an IBC self -assessment tool that can be found here. Q16. How many members must make up an IBC and who is qualified to do so? IBC's must have a minimum of 5 members. In Watertown, one* of those members must be a non-affiliated induvial who serves on a volunteer basis. The NIH website "FAQs on Institutional Biosafety Committee (IBC) Administration (May 2019)", has detailed information about the make-up, function, and administration of an IBC. * The regulation takes precedence where different from the NIH Guidelines Q17. What type of individual is appropriate for the "non-affiliated member" of the IBC? The "non-affiliated member" is meant to represent the interests of the surrounding community with respect to the environment and public health. Therefore, they should reside and/or work in Watertown, or reside in an adjacent municipality (Newton, Waltham, Cambridge, Allston - Brighton). The unaffiliated member of the IBC should have no relationship with the institution other than their volunteer service on the IBC. April 2020 Page 3 of 4 Watertown Biotechnology Regulation FAQ Q18. What is a Select Agent or Toxin? A Select Agent or Toxin is a biological agent or toxin that has been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. They are heavily regulated by the Federal Select Agent Program. A list of Select Agents and Toxins can be found here. Q19. What constitutes Dual Use Research of Concern (DURC)? Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. The United States Government's oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research (NIH Dual Use Research of Concern). Detailed information on the U.S. Government Policy for Institutional Oversight of Life Sciences DURC can be found here. April 2020 Page 4 of 4