2. Biological Safety Permit New Application

   Fee: $750.00

   You can pay this fee on our website through "Online Payments" or by check made out to "Town of Burlington" and mailed to: Burlington Board of Health 61 Center Street Burlington, MA 01803

6. This Application is for (check all that apply)*

   1. rDNA
   2. Risk Group 3 Agent
   3. Select Agent
8. Name of Facility*
9. Type of Business*
11. Facility Address*
13. City*
14. State*
15. Zip Code*

17. On-Site Emergency Facility Contact Information

19. Name*
20. Title*
22. Mailing Address*
24. City*
25. State*
26. Zip Code*
28. Day Phone Number*
29. 24 Hour Phone Number*
31. Email Address*
32. Fax Number

34. Biological Safety Officer Contact Information (if different from above)

36. Name
37. Title
39. Day Phone Number
40. 24 Hour Phone Number
42. Email Address
43. Fax Number

45. Corporate Officer Authorized to Sign Application

47. Name*
48. Title*
50. Day Phone Number*
51. 24 Hour Phone Number*
52. Email Address*
56. Protocol Name (Refer to BOH Protocol Form*)*

    *From Burlington BOH Protocol Form. This form must be submitted for every protocol. 

57. Regulated Agents Used*
59. NIH Risk Group*

    1. RG 1
    2. RG 2
    3. RG 3
    4. RG 4
60. Biosafety Containment Level*

    1. BL-1
    2. BL-2
    3. BL-3
    4. BL-1N
    5. BL-2N
    6. BL-3N
    7. BL-2+
    8. BL-1P
    9. BL-2P
    10. BL-3P
61. Reviewed and Approved by IBC*

    1. Yes
    2. No

63. Check boxes below to confirm the following new permit application requirements have been met/attached. Refer to the Burlington Board of Health Biological Safety Regulations for specific requirements.

65. Submit the following with new application

    1. Burlington BOH Biological Safety Protocol Form for All Protocols
    2. Table of all Protocols Reviewed and Approved by IBC
    3. Permit fee (make check payable to “Town of Burlington” or pay online)
    4. Description of Strain Verification Process/Protocol
    5. Biosafety Manual (See BOH Biological Safety Regulations, Section 7E and BMBL, Section III)
    6. Floor Plans (See BOH Biological Safety Regulations, Sections 7F & 7G)
    7. Emergency Response Plan (See BOH Biological Safety Regulations, Section 7G)
    8. IBC Roster & Minutes (See BOH Biological Safety Regulations, Sections 6D & 6C)
    9. Medical Surveillance Agreement (See BOH Biological Safety Regulations, Section 7H)
    10. Outline or Copy of Presentation to Board of Health at a Regularly Scheduled Meeting (See BOH Biological Safety Regulations, Section 7I)**
    11. Hazardous Material Registration Form (See Burlington Control of Toxic and Hazardous Material Bylaw: https://www.burlington.org/257/Hazardous-Materials)

    **Note:  Discussion of Permit Approval will be placed on a regularly scheduled BOH meeting agenda by the Director of Public Health when BOH staff has completed application review of submitted materials and all information has been received.

67. Certification of Compliance with NIH Guidelines and the BMBL*
68. Copies of IBC meeting minutes (prior year)*
70. Membership list of the IBC*
71. Report of Quality Assurance or Quality Improvement efforts (prior year)*
73. Additional Supporting Documents for Application

    Please upload any additional attachments to include with application.

75. FOR LABORATORIES USING BSL-3 CONTAINMENT OR RISK GROUP 3 AGENTS, SEE ADDITIONAL PERMIT APPLICATION REQUIREMENTS IN THE BOARD OF HEALTH BIOLOGICAL SAFETY REGULATIONS

    
    

    By signing below I hereby certify:

    1. All research or manufacturing involving Regulated Biological Agents as defined by the Burlington Board of Health Biological Safety Regulations shall be undertaken only in strict conformity with the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, if applicable, the current edition of the Centers for Disease Control (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL), and all other health regulations of the Board of Health;
    2. The facility will allow access for site inspections by the Burlington Board of Health; and, 
    3. The facility will provide a written summary of any incidents/adverse events in accordance with the Burlington Board of Health Biological Safety Regulations, Section 6G, if applicable.
77. Signature of Corporate Officer*

    This is an electronic signature to submit your application, there is no need to print or download this form for a physical signature.

78. Date*
    Date
Leave This Blank:


80. 1. Receive an email copy of this form.
81. Email address

    This field is not part of the form submission.

82. Submit Submit and Print

* indicates a required field