§ 198-6. Application and review process.

A. 

Biotechnology operating protocol permit.

(1) 

An applicant for a biotechnology operating protocol permit shall submit an application and an application review fee to the Board of Health, and shall file a copy thereof with the Town Clerk, Building Commissioner and Planning Board.

(2) 

The Board shall hold a public hearing within 45 calendar days of receiving a completed application and act upon the application within 30 calendar days of closure of the public hearing.

(3) 

The Board of Health may at any time reject as incomplete or inadequate any permit application which fails to provide the information required by this regulation.

(4) 

The applicant for a biotechnology operating protocol permit shall have the burden of convincing the Board that the activities proposed in the application meet or exceed the permit criteria herein. Failure to provide adequate evidence to the Board supporting this burden shall be sufficient cause for the Board to deny a permit. The Board may impose permit conditions which the Board deems necessary or desirable to protect human-health, safety-and-welfare.

(5) 

The Board shall render a written decision setting forth its findings and the reasons therefore. Such decision shall be filed in the office of the Town Clerk and copies mailed to the applicant, Building Commissioner and Planning Board.

(6) 

Institutions seeking such a biotechnology operating protocol permit from the Board of Health shall prepare and submit the following application materials:

(a) 

A plot plan showing the proposed location of the facility, the zoning classification of the site, building footprint, points of egress onto public ways, and available utilities.

(b) 

A detailed floor plan showing the following: internal layout of the facility; containment structures and equipment; and all points of egress, such as but not limited to:

[1] 

Sanitary disposal lines for sewage and wastewater.

[2] 

Laboratory or process waste lines.

[3] 

Building ventilation (natural and mechanical) exhausts and their respective quantity values of volumes/time and exit velocities.

[4] 

Solid, hazardous, biological and radiological wastes storage facilities.

(c) 

A listing of all organisms, containment levels and decontamination procedures to be employed.

(d) 

A plan, consistent with NIH guidelines, for a screening process for organisms used in experiments and for testing organisms resulting from such experiments.

(e) 

A plan, consistent with NIH guidelines, for a medical surveillance program for all employees engaged in the use of rDNA, together with the institution's health and safety manual. The health and safety manual shall include procedures required under NIH guidelines for the use of rDNA at all levels of containment in use at the facility, proper employee training and health surveillance programs, procedures for monitoring and minimizing potential environmental and personal exposure and a program for waste disposal in compliance with all applicable federal, state and local laws.

(f) 

A plan, consistent with NIH guidelines, for an environmental monitoring program. These shall include but not be limited to the following:

[1] 

A plan for the systematic monitoring of waste and waste processing.

[2] 

A plan to orient representatives of the institution's designated local hospital and the Franklin Board of Health, Fire Department and Police Department in the procedures to be used in the event of an emergency.

[3] 

A plan for systematic pest control management in laboratories, contiguous facilities and food service establishments in the same building.

[4] 

A plan for systematic security of the premises.

B. 

Fees. Any institution applying for a biotechnology operating protocol permit shall pay an application review fee while submitting its application to the Board of Health. Annually thereafter, a permit renewal fee shall be paid for each biotechnology operating protocol permit. Fee amounts are outlined in Chapter 82, Attachment 1, of Franklin's Town Code.

C. 

The Board of Health may select, retain and contract with a professionally competent person or agency to perform a review of any biotechnology operating protocol permit application. The payment for these services will be the responsibility of the applicant institution. Copies of documents resulting from such evaluations shall be submitted to the Franklin Planning Board as a party of interest, and for consideration during site plan review and, if applicable, the special permit approval process.

D. 

Confidentiality of proprietary documents. The Board of Health, its employees and any party contracted to conduct a permit application review shall maintain the confidentiality of any proprietary information released to them while performing their duties, and the institution may require a nondisclosure agreement to protect such proprietary information.