§ 198-5. Administrative requirements.  


Latest version.
  • A. 
    Each institution in the Town of Franklin engaging in biotechnology activities shall conform to applicable federal, state and local-health regulations which exist or may be promulgated. In addition, each institution experimenting-with or using rDNA technology shall comply with the administrative requirements set forth in the NIH guidelines, or any amendments thereof, established from time to time by the NIH, by other federal agencies or by act of Congress. No change in Franklin Board of Health regulations shall apply to work in progress or previously contracted for by an institution unless the Franklin Board of Health shall first hold a public hearing on such change after giving written notice to institutions in Franklin engaged in biotechnology activities.
    B. 
    Institutional biosafety committees.
    (1) 
    The nonaffiliated representatives on each IBC shall be appointed by the institution with approval by the Chairman of the Franklin Board of Health. These members shall be officials of local public health or environmental protection agencies or Franklin residents whose educational and/or professional backgrounds are appropriate to the IBC's function, e.g., persons with background in the legal, medical, occupational health or environmental fields.
    (2) 
    The nonaffiliated representatives on each IBC shall be bound to the same provisions as to nondisclosure and nonuse of proprietary information and trade secrets as all other members of the institutional biosafety committee, except to the extent necessary to alleviate any public health hazard.
    (3) 
    Each IBC shall meet no less than twice a year. Each IBC shall record minutes of each of its meetings, and a copy of all minutes of IBC meetings shall be forwarded to the Franklin Board of Health within 14 days of the meeting after first removing any proprietary information and trade secrets therefrom. The full text shall remain on file in the records of the institution for inspection at all reasonable times by any member of the IBC.
    (4) 
    Every six months, the IBC shall provide its certification that the institution remains in compliance with this regulation and any applicable NIH guidelines.
    C. 
    If the institution is engaged in rDNA research at the BSL-3 (BioSafety Level 3) containment level (as defined in the NIH guidelines), the institution shall appoint a biological safety officer (BSO) who shall be an additional member of the IBC.
    D. 
    If the institution is engaged in rDNA research on a large scale (as defined by the NIH), the institution shall comply with all additional administrative requirements contained in the NIH Large Scale Recommendations.