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The Maxine Singer Papers

Ordinance for the Use of Recombinant Molecule Technology in the City of Cambridge pdf (221,960 Bytes) transcript of pdf
Ordinance for the Use of Recombinant Molecule Technology in the City of Cambridge
After the Asilomar Conference of February 1975 had brought public attention to the potential environmental and health risk of the new technology of genetic engineering, municipal governments in Cambridge, Massachusetts, Berkeley, California, and San Diego sought to regulate recombinant DNA research conducted at universities within their jurisdiction. The municipal regulations adopted by the City of Cambridge went beyond the NIH guidelines on recombinant research in mandating, for example, that Institutional Biohazard Committees review boards that oversaw this research included members representing laboratory technicians (in addition to scientists) and that workers engaged in this research undergo specific safety training.
Number of Image Pages:
4 (221,960 Bytes)
1977-02-07 (February 7, 1977)
Sullivan, James L.
City of Cambridge, Massachusetts
Original Repository: Library of Congress. Maxine Singer Papers
Reproduced with permission of the City of Cambridge, Massachusetts.
Medical Subject Headings (MeSH):
DNA, Recombinant
Guidelines as Topic
Exhibit Category:
Risk, Regulation, and Scientific Citizenship: The Controversy over Recombinant DNA Research
Box Number: 33
Folder Number: 5
Unique Identifier:
Document Type:
Legislative acts
Physical Condition:
Series: Recombinant DNA File, 1972-1980, n.d.
SubSeries: Binders
Folder: Nos. 3-6, 1976 November-1977 February
Ordinance No. 874
Final Publication No. 1895. First Publication in the Chronicle Sun on January 27, 1977.
City of Cambridge
In the Year One Thousand, Nine Hundred Seventy-Seven
An Ordinance
In amendment to an Ordinance formerly entitled: "The General Ordinances of the City of Cambridge" as revised in 1972 and now designated as "The Code of the City of Cambridge."
Be it ordained by the City Council of the City of Cambridge as follows:
Chapter Eleven entitled: "Health and Housing" is hereby amended by adding at the end thereof a new Article II entitled: "Ordinance for the Use of Recombinant DNA Molecule Technology in the City of Cambridge" which reads as follows:-
Article II.
Ordinance for the Use of Recombinant Molecule Technology in the City of Cambridge.
Section 11-7. Guidelines for the Regulation of DNA Experimentation.
I. All recombinant DNA experiments in the City of Cambridge shall be undertaken only in strict conformity with the `Guidelines," so called, of the National Institute of Health (NIH), as set forth in the Federal Register dated September 9, 1976, or any amendment thereof, or as may be established from time to time by the NIH, by other Federal agency, or by Act of the Congress; and in conformity also with such other health regulations as the Commissioner of Health and Hospitals of the City of Cambridge may from time to time promulgate. Be it further ordained that these local regulations shall include, as of February 8, 1977, those additional guidelines set forth in Section 1, Articles I through V, of the report of the Cambridge Laboratory Experimentation Review Board to the Commissioner of Health and Hospitals on December 21, 1976, and as further set forth in the report of the Acting Commissioner of Health and Hospitals to this City Council on January 5, 1977, as follows:-
1. Institutions proposing recombinant DNA research or proposing to use the recombinant DNA technology shall prepare a manual which contains all procedures relevant to the conduct of said research at all levels of containment and that training in appropriate safeguards and procedures for minimizing potential accidents should be mandatory for all laboratory personnel. Said manual shall be submitted for review by the Cambridge Biohazards Committee as established in Section II of this ordinance.
2. The institutional Biohazards 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 bio-technicians staff and at least one community representative unaffiliated with the institution. The community representative should be approved by the Health Policy Board of the City of Cambridge.
3. All experiments undertaken at the P3 level of physical containment shall require an NIH certified host-vector system of at least an EK2 level of biological containment.
4. Institutions undertaking recombinant DNA experiments shall perform adequate screening to insure 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.
5. As part of the institutions' health monitoring responsibilities it shall in good faith make every attempt. subject to the limitation of the available technology, to monitor the survival and escape of the host organism or any component thereof, in the laboratory worker. This should include whatever means is available to monitor the intestinal flora of the laboratory worker.
6. All cases of unusual illnesses occurring in workers associated with all recombinant DNA research being carried out in the City of Cambridge be fully investigated and be reported in detail to the Commissioner of Health and Hospitals for the City of Cambridge.
Section 11-8. Establishment of a Cambridge Biohazards Committee.
II. A Cambridge Biohazards Committee (CBC) shall be established for the purpose of overseeing all recombinant DNA experimentation that is conducted in the City of Cambridge and of advising the Commissioner of Health and Hospitals and the Health Policy Board on the matters specified in Section B below.
A. The CBC shall be composed of the Commissioner of Public Health and his/her designee, the Chairperson of the Health Policy Board or a board member designated by the Chairperson and a minimum of thee other members to be appointed by the City Manager. The City Manager is authorized to provide for the adequate staffing of the CBC.
B. Specific responsibilities of the CBC shall include:-
1. Maintaining a relationship with the institutional biohazards committees.
2. Reviewing all proposals for recombinant DNA research to be conducted in the City of Cambridge for compliance with the "Guidelines," so called of the NIH as set forth in the Federal Register, dated September 9, 1976, or my amendment thereof. or as may be established from time to time by the NIH, by other Federal agency, or by Act of Congress: and in conformity with such other regulations as the Commissioner of Health and Hospitals of the City of Cambridge may from time to time promulgate.
3. Developing a procedure for members of institutions where the research is carried on to report to the CBC violations either in technique or established policy.
4. Reviewing reports and recommendations from local institutional biohazards committees.
5. Carrying out site visits to institutional facilities.
6. Seeing that conditions set forth in Section 11-7 of this ordinance are adhered to.
7. Recommending to the Commissioner of Health and Hospitals modifications in those conditions to reflect future developments in Federal guidelines. It shall be the responsibility of the institutional Biohazards Committee to file regular reports with the Cambridge Biohazards Committee, in a manner to be determined by the CBC.
8. The premises on which all P2 and P3 recombinant DNA experiments are carried out must be effectively free of rodent and insect infestation, in accordance with all laws governing such matters.
9. Violation of the conditions of this ordinance shall subject the violator to a fine of Two Hundred Dollars ($200.00) per day and in addition the facility in which the violation occurs may be closed by the Commissioner of Health and Hospitals. Each day of violation shall constitute a separate and distinct offense.
10. Recombinant DNA experiments classified by NIH Guidelines as more potentially hazardous than those requiring 3 P3 plus EK2 level of containment shall not be permitted in the City of Cambridge.
Recombinant DNA experiments which are classified by the NIH to lower containment levels other than those contained in the June 23, 1976 NIH Guidelines, must be reviewed and approved by the CBC.
Section 11-9. Severability of Sections.
If any section, sub-section, sentence, clause, phrase or portion of this ordinance 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.
In City Council February 7, 1977.
Passed to be ordained as amended by a yea and nay vote:- yeas 9; Nays 0; Absent 0.
James L. Sullivan, City Manager.
Attest:- Paul E. Healy, City Clerk.
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