Loading...
HomeMy Public PortalAbout2022 Renewal letter and Low Risk BioSafety FillTOWN OF WATERTOWN Board of Health Administration Building 149 Main Street Watertown, MA 02472 Phone: 617-972-6446 Fax: 617-972-6499 www.watertown-ma.gov Larry Ramdin, MPH, REHS, CHO, CP-FS Director of Public Health 2022 RENEWAL BIOSAFETY APPLICATION FOR PERMIT OR REGISTRATION TO OPERATE BIOSCIENCE LABORATORY Dear Applicant: Please find an enclosed 2022 Renewal Application for Permit or Registration to Operate a BioScience Laboratory. It is required that you complete the attached application and return to the Watertown Health Department with the following documentation to be reviewed by Watertown BioSafety Committee: • Completed Application for Permit or Registration to Operate a BioScience Laboratory (a. or b.) a. Recombinant DNA (rDNA) and/or Biologic Agents Permit BLS1, BLS2 - $500.00 b. Recombinant DNA (rDNA) use by Low -Risk Facilities BLS1 - $100.00 • Provide all the supplemental documents listed on the application with your submission of this application • Provide an electronic copy of the application and supplemental documents • Submit correct Permit or Registration Fee(s), checks payable to "Town of Watertown", see application. • Must submit the most recent IBC meeting minutes. (All applicants must have had at least one IBC meeting since January 1, 2021) Watertown Health has established guidelines and regulations regarding permitting laboratories within the community. The biosafety renewal applications must be received by December 31, 2021 with your payments and completed applications. The permit fee for Recombinant DNA (rDNA) and/or Biologic Agents Permit BLS 1, BLS2 is $500.00 and the fee for Recombinant DNA (rDNA) use by Low -Risk Facilities BLS1 is $100.00 make your payments payable to "Town of Watertown". Completed applications and all supporting documentation must be received prior to December 31, 2021. Late fee of fifty dollars ($50.00) will be assessed for non -submittal of all applications and/or incomplete application packets received after December 31, 2021. Please note that any missing information may cause a delay in the permit renewal process. Thank you for your attention to this matter and your anticipated compliance. Should you have any questions please contact this office at (617) 972-6446. Sincerely, Director of Public Health TOWN OF WATERTOWN Board of Health Administration Building 149 Main Street Watertown, MA 02472 Phone: 617-972-6446 Fax: 617-972-6499 www.watertown-ma.gov 2022 Renewal Registration of Recombinant DNA (rDNA) use by Low -Risk Facilities Please provide electronic version of your application and supporting documents To the Watertown Board of Health: The undersigned seek to register our use of rDNA pursuant to the Town of Watertown's Board of Health regulation: Biotechnology and the use of Recombinant DNA Molecule Technology. Biosafety Containment Level (check all that apply): ❑ BSL-1 ❑ BSL-2 Institution / Company Information: Name of the Institution: Address: Mailing Address (If Different): Phone: Email: Fax: Date of Occupancy: Institutional Official / Responsible Official / Chief Executive Officer (CEO): Name: Work Address: Phone (Office): Email: Phone (cell): ❑Check if contact person for permit -related communication Contact Person (if not selected above): Name: Work Address: Phone (Office): Email: Phone (cell): Please provide for the RENEWAL the following documentation: ❑ Completed and signed use of rDNA registration form. ❑ Check or money order payable to the Town of Watertown for $100.00. Name and curriculum vitae of a person in the organization familiar with the proposed rDNA Work and with the NIH Guidelines. ❑ This signed form with up-to-date company contact information. A one -page summary of work performed over the past year. Including: a. name and type of organisms (host/donor [foreign DNA]/vector) being used. b. reference to the section of the NIH Guidelines where the work falls. c. approximate percentage of viral genome present, if rDNA containing eukaryotic viruses are propagated in cells. d. scale (in liters) on which the organisms will be grown. Any initial documents that have changed significantly (ex. new waste management company, new pest control company, etc.) II Agreement and Signature 1. We, the undersigned, do hereby certify and affirm that all the information provided in this application, including all attached documents, is true and accurate to the best of our knowledge and belief. 2. We certify that we shall conduct work specified in this application in compliance with the Town of Watertown's Board of Health regulation entitled Biotechnology and the use of Recombinant DNA Molecule Technology. 3. We understand that, under the above -mentioned regulation, only facilities that have a biosafety contentment level no higher than BSL-1, and are defined as a Low -Risk Facility, are allowed to register in place of seeking a permit. 4. We understand that an amendment to this registration must be sought prior to annual renewal in the following instances: move to a new location within the Town of Watertown, physical expansion of lab space within current facilities, creation of additional lab space at another location in the Town of Watertown, and/or the addition of Large -Scale activities as defined in Appendix K of the NIH Guidelines. Amendments to the registration must be approved before the above -mentioned changes can proceed. 5. We are aware that an increase in containment level above BSL-1 requires us to seek a permit prior to the commencement of work. 6. We agree and consent to inspection of our facilities, procedures, and practices in order to confirm compliance with the above -mentioned regulation and all applicable federal, state and local laws by the Board or Health or its Agents at reasonable times. Inspections may be conducted annually or with greater frequency if deemed necessary by the Board of Health. Institutional Official / Responsible Official / CEO Date (Signature) Institutional Official / Responsible Official / CEO (Printed) Date