N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 61-1.30

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

Section 61-1.30 - Institution; responsibilities

Except as otherwise provided by subdivision (c) of section 61-1.3 of this Subpart, the institution shall:

(a) submit to the commissioner a written assurance complying with the requirements of paragraph (2) of subdivision (a) of section 61-1.3 of this Subpart unless it possess a certificate pursuant to subdivision (b) or (d) of said section;

(b) establish an institutional biosafety committee (IBC) that meets the requirements of section 61-1.31 of this Subpart;

(c) ensure that the institutional biosafety committee is fulfilling its responsibilities at all times;

(d) ensure compliance of recombinant DNA activity with the requirements of this Subpart;

(e) if the institution is engaged in recombinant DNA activity at the P3 or P4 containments level, appoint a biological safety officer (BSO), who shall be a member of the IBC and carry out the duties specified in section 61-1.32 of this Subpart;

(f) ensure that all principal investigators (PIs) comply with the provisions of section 61-1.33 of this Subpart;

(g) ensure appropriate training for the IBC chairperson and members, the BSO, principal investigators (PIs), and laboratory staff regarding the requirements of article 32-A of the Public Health Law and this Subpart, their implementation and laboratory safety;

(h) determine, in consultation with the local public health office when appropriate, the necessity and extent of health surveillance of personnel involved in recombinant DNA activity, including, but not limited to records of agents handled, active investigation of illnesses of personnel working with or exposed to recombinant DNA, and maintenance of serial serum samples;

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

(j) upon request, make available to the public any documents submitted to or received from the commissioner which he is required to make available to the public (e.g., reports of violations of this Subpart and of significant recombinant DNA activity-related accidents, and directives to modify projects). If comments are made by members of the public on IBC actions, the institution shall forward to the commissioner both the comments and the IBC's response.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 61-1.30

See NIH Laboratory Safety Monograph for additional medical surveillance information.