N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 61-1.3

Current through Register Vol. 46, No. 45, November 2, 2024

Section 61-1.3 - Certification

(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) 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) submits a written assurance that it:

(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;

(ii) will file reports with the commissioner when requested by him showing the progress of recombinant DNA activity engaged in at the institution;

(iii) will not engage in recombinant DNA activity in any facility which does not comply with the NIH guidelines;

(iv) will conduct training programs satisfactory to the commissioner for all workers and service personnel with duties in recombinant DNA laboratories;

(v) will carry out health monitoring programs appropriate to each recombinant DNA activity engaged in;

(vi) has an emergency plan for accidents involving potentially hazardous materials involved in recombinant DNA activity; and

(vii) will comply with the requirements of article 32-A of the Public Health Law and this Subpart.

(b) An institution engaged in recombinant DNA activity subject to, and in compliance with, policies and regulations or guidelines promulgated by any agency of the Federal government for the regulation of recombinant DNA activity may submit to the commissioner copies of the documentation approved by the Federal agency, including information relating to the institutional biosafety committee of the institution. Such documentation may be accepted by the commissioner as authority for issuance of a certificate to engage in recombinant DNA activity upon the same conditions and limitations, if any, as imposed by the Federal agency.

(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) those that are not in organisms or viruses;

(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) 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) 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) 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.

(d) An institution not otherwise covered by the NIH guidelines, and not having a valid certificate pursuant to subdivision (c) of this section, is prohibited from engaging in recombinant DNA activity covered by this Subpart unless it follows the approval procedures set forth in Part VI, Voluntary Compliance, of the NIH guidelines. Upon being provided with satisfactory evidence thereof, the commissioner will issue a certificate to the institution to engage in recombinant DNA activity.

(e) Subject to the right to a hearing pursuant to section 12-a or section 16 of the Public Health Law, the commissioner may revoke or suspend the certificate of an institution upon proof that it is conducting or has conducted recombinant DNA activity requiring approval by NIH or other Federal agency designated by NIH, or approval pursuant to subdivision (d) of this section where required, without such approval.

(f) A host-vector system which is not expressly authorized by this Subpart cannot be used unless the institution registers the recombinant DNA activity with NIH and requests evaluation by NIH of the host-vector system. Cloning activity prior to certification of such host-vector system by NIH shall be limited to those genes which are characterized and are usable for evaluation of the host-vector system in its early stages of development.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 61-1.3