City of Waltham, MA
Middlesex County
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Editor's Note: Ordinance No. 24883, adopted Jan. 12, 1981, amended the Code by adding provisions designated as Ch. 22, which provisions have been redesignated by the editor as §§ 7.5-21—7.5-24 for purposes of classification and in order to maintain the alphabetical sequence of chapters.
Cross reference—Health department, § 2-106 et seq.
[Ord. No. 24883, 1-12-1981; Ord. No. 28126, 5-13-1996]
NIH Guidelines. The experimentation with or use of recombinant DNA technology in the city shall be undertaken only in strict conformity with all applicable provisions of the General Ordinances of the City of Waltham, and the guidelines, so-called, of the National Institute of Health (NIH), as set forth in the Federal Register of May 7, 1986, or any amendment thereof, or as may be established from time to time by the NIH, by any other federal agency or by any Act of Congress; and in conformity also with such other health regulations as the Board of Health of the City of Waltham may from time to time promulgate; provided, however, that no change in the city health regulations shall apply to work in progress or previously contracted for by an institution unless the Board of Health shall first hold a public hearing on such change giving written notice to institutions in Waltham carrying on recombinant DNA work, and by advertisement in a newspaper of general circulation within the city at least once 10 days in advance.
Manual. Individuals, associations, organizations, corporations, educational institutions or medical facilities (all hereinafter referred to as "institutions") proposing to experiment with or use recombinant DNA technology, as defined and regulated by the NIH guidelines, shall prepare a manual, which contains all procedures included in the NIH guidelines, to regulate said uses at all levels of containment in use at the institution. Training in appropriate safeguards and procedures for minimizing potential accidents shall be mandatory for all laboratory personnel. Said manual, and all amendments thereto, shall be submitted in a timely manner to the Waltham Biosafety Committee for its review.
Waltham Biosafety Committee established. There is hereby established a Waltham Biosafety Committee (WBC). Committee members shall be classified as special municipal employees.
Composition of WBC. The Waltham Biosafety Committee (WBC) shall be composed of the Director of Public Health or his/her designee, the Chairperson of the Board of Health or a board member designated by the Chairperson, and three other members to be appointed by the Mayor, subject to confirmation by the City Council, for terms of one year from the first day of January and until their successors are appointed and confirmed. The members of the WBC shall organize annually by electing one member as Chairperson.
Powers and duties of WBC. The powers and duties of the WBC shall be as follows:
Recommending and reviewing proposals for regulations to be promulgated pursuant to this article, and advising the Board of Health regarding the adoption of said regulations.
Determining the manner in which permit holders make reports to the WBC and the type of information required in such reports; reviewing reports and recommendations by the Institutional Biosafety Committee (IBC) and approving them where appropriate; conducting site visits to permitted facilities.
Reviewing manuals and worker training programs, approving health-safety programs and monitoring compliance with the requirements of this article and all regulations promulgated thereunder.
Developing procedures for persons to report to the WBC violations of this article or any regulations promulgated thereunder and making recommendations to the Board of Health regarding the enforcement of the same.
Reviewing all applications for permits under this article and making recommendations to the Board of Health regarding the granting, renewal, suspension or revocation of such permits.
Permit requirements. All persons proposing to use RDNA must obtain a permit from the Board of Health, which may issue such permit after a review of the application by the WBC. Permit requirements shall, at a minimum, include written agreement to:
Follow the guidelines as defined in this article, and any regulations duly adopted by the Board of Health pursuant to the provisions of this article.
Adhere to any restrictions that may be required by the Board of Health as a condition of granting such permit.
Allow reasonable inspections of facilities and pertinent records by the WBC or the Director.
Prepare a health and safety manual and establish a training program as required by Subsection (b) of this section.
Permit fees and renewals. Permits shall take effect on the date on which they are issued, and shall be renewed annually. The fee for issuance or renewal of any such permit shall be $300.
Institutional Biosafety Committee required. For each organization receiving a permit under this chapter there shall be established an Institutional Biosafety Committee (IBC). Committee members shall be classified as special municipal employees.
Composition of Institutional Biosafety Committee. The Institutional Biosafety Committee mandated by the NIH guidelines should be broad based in its composition. It should include members from a variety of disciplines, representation from the biotechnician's staff and it shall include at least two community representatives who shall be appointed by the Mayor, one of whom shall be the Director of Public Health and both of whom shall have no financial interest in the institution or any other institution in competition therewith, and such two representatives shall be bound to the same provisions as to nondisclosure and nonuse of proprietary information and trade secrets as all other members of the Institutional Biosafety Committee, except to the extent necessary to alleviate any public health hazard. As used in this article "proprietary information and trade secrets" shall be defined as set forth under the law of the Commonwealth of Massachusetts.
Minutes of meetings of IBC. The minutes of all meetings of the Institutional Biosafety Committee shall be delivered to the Director and the WBC within 10 days of the meeting, after first removing any proprietary information and trade secrets therefrom. The full text shall remain on file in the records of the institution for inspection at all reasonable times by any member of the IBC or the WBC.
Screening of hosts; testing of resultant organisms. Institutions undertaking research with or use of recombinant DNA technology as defined by and regulated by the NIH guidelines 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.
Medical surveillance program.
All institutions are to provide an appropriate medical surveillance program as determined by the IBC for all persons engaged in experimentation with or use of recombinant DNA technology, as defined by and regulated by the NIH guidelines. Such programs must be approved by the WBC.
As part of the institution's health monitoring responsibilities it shall, in good faith, make every attempt, subject to the limitation of the available technology, to apply monitoring of the organism involved appropriate to the degree of hazard as determined by the IBC, in the laboratory worker and inside and outside the containment laboratory. This shall include whatever means are available to monitor the intestinal flora of the laboratory worker.
The permit holder shall report, within 30 days, to the Director and the WBC any significant problems with or violations of the guidelines and any significant RDNA-related accidents or illnesses.
Protection against rodents and insects. Effective rodent and insect control programs must be in place on the premises where RDNA use, under this article, takes place.
Regulations. The Board of Health may adopt, subject to review by the WBC and approval by the City Council, such rules and regulations as may be necessary to effectively implement the provisions of this article.
[Ord. No. 24883, 1-12-1981]
Experimentation with, or use of, recombinant DNA technology, classified by NIH guidelines as requiring P4 level of containment, shall not be permitted in the city.
The use of humans as experimental subjects in recombinant DNA research, as defined and regulated by the NIH guidelines, shall not be permitted in the city.
[Ord. No. 24883, 1-12-1981]
A violation of any of the provisions of this article shall subject the violator to a fine of $200 per day and, in addition, the specific laboratory in which the violation occurs may be closed by the director. Each day of violation shall constitute a separate and distinct offense; provided, however, that no monetary fine shall be imposed for any violation which occurred at any time before the day of written notice of the violation by the city to the institution.
[Ord. No. 24883, 1-12-1981]
If any section, subsection, sentence, clause, phrase or portion of this article 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.