(a) A certificate to engage in recombinant DNA activity will be issued by the commissioner only to an institution. Except as hereinafter provided, an institution will not be issued a certificate unless it:

1. (1) establishes an institutional biosafety committee (IBC) composed of members approved by the commissioner as satisfying the requirements of section 61-1.31 of this Subpart; and

2. (2) submits a written assurance that it:

   1. (i) will submit each recombinant DNA project to NIH, or other Federal agency designated by NIH, for approval where such approval is required by this Subpart or the NIH guidelines;
   2. (ii) will file reports with the commissioner when requested by him showing the progress of recombinant DNA activity engaged in at the institution;
   3. (iii) will not engage in recombinant DNA activity in any facility which does not comply with the NIH guidelines;
   4. (iv) will conduct training programs satisfactory to the commissioner for all workers and service personnel with duties in recombinant DNA laboratories;
   5. (v) will carry out health monitoring programs appropriate to each recombinant DNA activity engaged in;
   6. (vi) has an emergency plan for accidents involving potentially hazardous materials involved in recombinant DNA activity; and
   7. (vii) will comply with the requirements of article 32-A of the Public Health Law and this Subpart.

(c) Unless the activity is prohibited by section 61-1.2 of this Subpart, an institution may be issued a certificate by the commissioner to engage in recombinant DNA activity limited to the following recombinant DNA molecules, and for such certificate shall not be required to comply with those provisions of sections 61-1.30 and 61-1.31 of this Subpart pertaining to the establishment and functioning of an institutional biosafety committee (IBC):

1. (1) those that are not in organisms or viruses;
2. (2) those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent;
3. (3) those that consist entirely of DNA from a prokaryotic host, including its indigenous plasmids or viruses, when propagated only in that host (or a closely related strain of the same species) or when transferred to another host by well-established physiological means; also those that consist entirely of DNA from a eukaryotic host, including its chloroplasts, mitochondria or plasmids (but excluding viruses), when propagated only in that host (or a closely related strain of the same species);
4. (4) certain recombinant DNA molecules that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent, as specified in a list of such exchangers prepared and periodically revised by the director, NIH; and
5. (5) other classes of recombinant DNA molecules if the director, NIH, finds that they do not present a significant risk to health or the environment, and the commissioner is furnished satisfactory evidence of such finding.