Loading...
All institutions using RDNA on a “Large Scale” (as defined in the “Guidelines”) must adhere to the following requirements in addition to those stated in Subsection 17-9.1.
(A) (1) All institutions intending to engage in large-scale procedures must obtain a special, large-scale permit from the Board, which must be renewed annually, prior to commencing such procedures. Said permit shall be separate and distinct, but otherwise in addition to the permit required by Subsection 17-9.1.
(2) Such Large-Scale Permit shall require, at minimum, written agreement to:
(a) Identify clearly all large-scale RDNA use in their IBC minutes;
(b) Develop procedures through their IBC for monitoring large-scale operations for compliance with this Section and the “Guidelines”, to be approved by the Commissioner; and
(c) Establish a Health-Safety Program for appropriate employees which shall include periodic health surveillance which must be approved by the Commissioner.
(B) The Commissioner shall cause any facility using Large-Scale RDNA to be inspected no less than annually.
(C) Prior to issuing any Large-Scale Permit the Board shall conduct an appropriate public hearing.
(Ord. 1981 c. 12 § 2; CBC 1985 17-9.2) Penalty, see Subsection 17-9.6
Recognizing the need for community and scientific input to assist the Board and the Commissioner in carrying out their duties and responsibilities in regulating Recombinant DNA research, production and technology, the BBC, as established by Subsection 17-9.1(C), shall have the following duties and responsibilities.
(A) The BBC shall continually review literature in the area of Recombinant DNA research, production and technology and shall continually review the effectiveness of the regulatory system established by this Section and, in light of such review, shall advise and make recommendations to the Commissioner and the Board as to the manner in which the system may be improved. Included within such responsibilities, the BBC shall review and make recommendations to the Commissioner on all amendments to the “Guidelines”.
(B) The BBC shall review and make recommendations to the Board on all applications for permits and permit renewals.
(C) The BBC shall review, comment and make recommendations to the Commissioner on individual institution’s policies, procedures, manuals and programs adopted by such institution for the purpose of conforming with the requirements of this Section and its permit.
(D) The BBC shall designate one of its members, other than the Commissioner, to participate in site inspections carried out under this Section.
(E) The BBC shall designate one or more of its members to participate in public hearings held by the Board in the area of Recombinant DNA regulation or permitting.
(F) The BBC shall review and make recommendations to the Commissioner and the Board in regard to appropriate administrative action to be taken for violations of this Section.
(G) The BBC shall make an annual report to the Board, the nature and content of which shall be determined by the BBC, as to the status of RDNA research, technology and production activities within the city and the effectiveness of the regulatory system as established by this Section.
(H) The BBC shall meet at least six times per year but otherwise with sufficient frequency to assure prompt and effective response to its duties and responsibilities.
(Ord. 1981 c. 12 § 3; CBC 1985 17-9.3)
(A) RDNA use requiring containment defined by the “Guidelines” as “P4” shall not be permitted in the city.
(B) There shall be no deliberate release into the environment of any surviving organism containing recombinant DNA and any accidental release shall be reported to the Commissioner immediately and in no case longer than 24 hours.
(Ord. 1981 c. 12 § 4; CBC 1985 17-9.4) Penalty, see Subsection 17-9.6
The Commissioner is hereby authorized and directed to design, implement and enforce a fee system which shall assure that activities carried out by the city and the BBC in conformance with this Section are fully reimbursed by the regulated institutions. Payment of such fee or fees shall be a further condition of the granting or renewing of any permit.
(Ord. 1981 c. 12 § 5; CBC 1985 17-9.5)
(A) Violation of the conditions of this Section shall subject the violator to a fine of $200 per day. Each day of violation shall constitute a separate and distinct offense.
(B) Once a permit has been issued it may be revoked, suspended or modified by the Commissioner, or not renewed by the Board, only upon a determination, after due notice and hearing, that the institution involved has materially failed to comply with this Section, the permit agreements or the “Guidelines”. Notice and hearing procedures shall be those established by the Environmental Health Inspection Services Division of the Department of Health and Hospitals.
(C) Notwithstanding the above, the Commissioner, upon a determination that any violation constitutes an immediate and severe threat to the public health and safety, may order the immediate closure of any premises or laboratory engaging in or contributing to such threat, without prior notice and hearing but otherwise with subsequent notice and hearing.
(Ord. 1981 c. 12 § 6; CBC 1985 17-9.6)
If any Section, Subsection, sentence, clause, phrase or portion of this Section is for any reason held invalid or unconstitutional by any court of competent jurisdiction, such portion shall be deemed a separate, distinct and independent provision, and such holding shall not affect the validity of the remaining portions thereof.
(Ord. 1981 c. 12 § 7; CBC 1985 17-9.7)
This Section shall be in full force and effect until July 1, 1991 unless sooner amended, repealed or extended. Nothing contained herein shall be construed to limit the term or effectiveness of any regulations promulgated by the Board of Health and Hospitals during or subsequent to such period.
(Ord. 1981 c.12 § 8; Ord. 1986 c. 9, §§ 1, 2; CBC 1985 17-9.8)
Editor’s note:
Section 2 of Ord. 1986 c. 9 states “The remaining parts and portions of said Chapter 12 of the Ordinances of 1981 are hereby continued and confirmed to the end that the said ordinance shall be deemed to not have lapsed and to be and remain continuously in force and effect until July 1, 1991 unless sooner amended, repealed or extended”. Ord. 1991 c. 3 provides that Chapter 12 of Ordinance 1981 shall be in full force and effect until January 1, 1993.
Loading...