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Title: Section 61-1.31 - Institutional biosafety committee; composition and duties

61-1.31 Institutional biosafety committee; composition and duties.

(a) An institutional biosafety committee (IBC) shall be composed of not less than five persons, approved by the commissioner, who collectively have experience and expertise in recombinant DNA technology and the capability to assess the safety of proposed recombinant DNA activity and any potential risk to public health or the environment. At least two members shall not be affiliated with the institution (apart from their membership on the IBC) and shall represent the interest of the surrounding community with respect to health and protection of the environment. Members meet this requirement if, for example, they are officials of State or local public health or environmental protection agencies, members of other local governmental bodies, or persons active in medical, occupational health, or environmental concerns in the community. The biological safety officer (BSO), mandatory when activity is being conducted at the P3 and P4 levels, shall be a member. The membership should include individuals with expertise in recombinant DNA technology, biological safety and physical containment and include, or have available as consultants, persons knowledgeable in institutional commitments and policies, applicable law, standards of professional conduct and practice, community attitudes and the environment. At least one member should be from the laboratory technical staff. No member of a committee may be involved (except to provide information requested by the IBC) in the review or approval of activity in which he or she has been, or expects to be, engaged, or has a direct or conflicting interest.

(b) IBC meetings and minutes of meetings shall be open to the public, consistent with protection of privacy and proprietary interests.

(c) On behalf of the institution, the IBC shall:

(1) review for compliance with this Subpart all recombinant DNA activity as specified in section 61-1.20 of this Subpart conducted at or sponsored by the institution, and approve those activities that it finds are in conformity with this Subpart. This review shall include:

(i) an independent assessment of the containment levels required by this Subpart for the proposed activity; and

(ii) an assessment of the facilities, procedures and practices, and of the training and expertise of the recombinant DNA personnel;*

(2) notify the principal investigator (PI) of the results of their review;

(3) lower containment levels for certain experiments as specified in section 61-1.20 of this Subpart: class III-B-2;

(4) set containment levels as specified in section 61-1.20 of this Subpart: class III-B-4-b and III-B-5;

(5) review periodically recombinant DNA activity being conducted at the institution, to ensure that the requirements of this Subpart are being fulfilled;

(6) adopt emergency plans covering accidental spills and personnel contamination resulting from such activity;*


FOOTNOTE: * See NIH Laboratory Safety Monograph for additional details.


(7) report within 30 days to the appropriate institutional official and to the commissioner any significant problems with or violations of this Subpart, and any significant recombinant DNA activity-related accidents or illnesses, unless the IBC determines that the PI has done so;

(8) maintain appropriate records, including copies of proposals reviewed, minutes of IBC meetings, reports of accidents and illnesses, and records of periodic review;

(9) authorize initiation of no experiment not explicitly covered by this Subpart until NIH establishes the containment requirement; and

(10) perform such other functions as may be delegated to the IBC by the institution consonant with its responsibilities.


VOLUME A-1a (Title 10)