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Whoever violates any provision of Subsection 17-8.1 or whoever makes a false or fraudulent representation in making an application under Subsection 17-8.2, or whoever neglects or fails to file supplementary writings as required by Subsection 17-8.2 shall be subject to a fine of $50 for each day on which such violation occurs or during which such violation continues.
(Rev. Ord. 1961 (Sup. 1971) c. 28 § 23C; CBC 1975 Ord. T14, § 425; CBC 1985 17-8.3)
Editor’s note:
See note above.
(A) Definitions. For the purpose of this Section, the following definitions shall apply unless the context clearly indicates or requires a different meaning.
GUIDELINES.
(a) National Institutes of Health Guidelines for Research Involving Recombinant DNA molecules as published in the Federal Register of November 21, 1980.
(b) National Institute of Health Physical Containment Recommendations for large-scale use of organisms containing Recombinant DNA molecules as published in the Federal Register on April 11, 1980.
(c) Administrative Practices Supplement to NIH Guidelines for Research involving Recombinant DNA molecules as issued by the Office of Recombinant DNA Activities, November, 1980.
(d) Such amendments to divisions (a), (b) and (c) above which are adopted by NIH and approved by the Commissioner. Amendments not acted upon by the Commissioner within 60 days shall be considered approved.
INSTITUTION. Any single individual, group of individuals or organization.
RECOMBINANT DNA MOLECULES (RDNA) and ORGANISMS AND VIRUSES CONTAINING RDNA. As defined in the National Institutes of Health Guidelines promulgated in the Federal Register on November 21, 1980, and such amendments thereto as may be approved by the Commissioner of Health and Hospitals (“Commissioner”). Amendments not acted upon by the Commissioner within 60 days shall be considered approved.
(B) Purpose. All use of RDNA by institutions in the city shall be undertaken only in strict conformity with the “Guidelines”, as defined in division (A) above, and in conformity with such other health regulations as the Board of Health and Hospitals (Board) may, from time to time, promulgate or administrative practices which the Commissioner may, from time to time, require.
(C) Boston Biohazards Committee.
(1) A Boston Biohazards Committee (“BBC”) shall be established within 30 days of the time of passage of this Section for the purpose of overseeing all use of RDNA within the city and of advising the Commissioner and the Board, all in accordance with the powers and the duties assumed pursuant to Subsection 17-9.3.
(2) The BBC shall be composed of seven members, one of whom shall be the Commissioner, or his or her designee, who shall serve as Chair; two of whom shall be residents of neighborhoods which are or may be impacted by RDNA research or technology; one of whom shall be a scientist knowledgeable in the field of RDNA research or technology; and three of whom shall assure representation from the fields of public health, occupational health and infectious diseases. Members shall be appointed by the Mayor, subject to confirmation by the Boston City Council, except for the two community representatives. Each neighborhood impacted by RDNA research or production may nominate a delegate to attend and participate in meetings of the BBC. The Commissioner shall arrange with an established community group in each such neighborhood to conduct an election, at no cost to the city, to nominate such delegates. Neighborhood delegates will arrange among themselves at the first meeting of the BBC in each year which delegates shall hold the voting memberships provided in this Section. The members as appointed by the Mayor shall serve for terms of three years, except that one member initially appointed to represent a neighborhood which is or may be impacted by RDNA research or technology and one member initially appointed to assure representation from the fields of public health, occupational health or infectious disease shall be initially appointed for terms of two years; and the other two members initially appointed to assure representation from the fields of public health, occupational health or infectious disease shall be initially appointed for terms of one year. Persons appointed by the Mayor to fill vacancies shall serve for the unexpired term of said vacancy. Appointments not acted upon by the Boston City Council shall automatically take effect after 21 days.
(3) Upon the request of the BBC, the Commissioner shall make available competent professional assistance to assist the BBC in carrying out its duties under this Section.
(D) Permit requirements.
(1) All institutions proposing to use RDNA must obtain a permit from the Board which must be renewed annually. Permit requirements shall, at minimum, include written agreement to:
(a) Following the “Guidelines” as defined in Subsection 17-9.1;
(b) Follow other conditions as set forth in this Section;
(c) Allow inspections, at reasonable times, of facilities and pertinent records;
(d) Prepare a Health and Safety Manual which contains all procedures relevant to the use of RDNA at all levels of containments at use at the institution;
(e) Establish a training program of safeguards and procedures for personnel using RDNA; and
(f) Submit, to the BBC, for approval by the Commissioner, a plan for the systematic monitoring of research and production waste to assure that surviving RDNA organisms are not released into the environment. Said plan shall include provisions that no surviving RDNA organisms are released into the city’s sewerage system.
(2) Applications for permits must be acted upon within 60 days, unless such applications involve physical containment defined by the “Guidelines” as “P2” or “P3” or are defined by the “Guidelines” as “large scale” activities, in which case applications must be acted upon within 90 days. Failure to act within such time period shall constitute an approval.
(3) Any institution which has not commenced RDNA activity as of the effective date of this Section may not proceed until a permit is issued. All other institutions must apply for such permits within 60 days of the effective date of this Section.
(E) The Institutional Biosafety Committees (“IBCs”), shall be established in accordance with the “Guidelines”, except that the required composition of the committees shall include at least one representative of the local community approved by the Commissioner and at least one non-doctoral person from the laboratory technical staff.
(F) The Commissioner may require the forwarding of minutes of IBC meetings and may also require the filing of regular reports, all in a manner to be determined by him or her. To the extent IBC minutes may contain trade secrets or proprietary information the Commissioner and the Institution shall develop procedures for assuring confidentiality.
(G) Institutions using RDNA shall perform adequate screening to ensure the purity of the strain of host organisms used in the experiments and shall test organisms resulting from such experiments for their resistance to commonly used therapeutic antibiotics.
(H) (1) All institutions using RDNA shall provide an appropriate medical surveillance program as determined by their IBC for all persons engaged in the use of RDNA. Such programs must be submitted to and approved by the Commissioner and shall include, but shall not necessarily be limited to:
(a) A medical examination for employees prior to their employment in a laboratory or area engaged in RDNA research or technology;
(b) Prompt reporting of significant or potentially related employee illnesses to their IBC; and
(c) Retention of medical and health records for a period of time to be determined by the Commissioner.
(2) The Commissioner, with the advice and recommendations of the BBC, may set minimum standards for medical examinations, employee illness reporting and medical and health records, and may likewise require, for specified levels of physical containment or large-scale use, the taking of serum samples at the time of employment and their maintenance to permit future testing. The Commissioner and the institution shall develop procedures to assure that the confidentiality of employee health and medical records are protected.
(I) The institution shall report within 30 days to the Commissioner and the BBC any significant problems with or violations of the “Guidelines” and any significant RDNA related accidents or illnesses.
(J) All areas in which RDNA is utilized shall be free of rodent and insect infestation.
(Ord. 1981 c. 12 § 1; CBC 1985 17-9.1) Penalty, see Subsection 17-9.6
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)
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