The Boston City Council will review a revised proposal for regulation of recombinant DNA (RDNA) research at local facilities--including Harvard Medical School-at its meeting tomorrow afternoon.
The proposal, a reworking of an original version presented to the council on May 19, would establish mandatory guidelines for universities conducting recombinant DNA research. The proposal would mandate compliance with National Institutes of Health (NIH) standards.
The new proposal represents the findings of a special committee of local scientists, formed after the Council tabled discussion of the original proposal on May 27.
The long-running controversy surrounding DNA research was rekindled recently by news of a $60-million grant given to the Harvard-affiliated Massachusetts General Hospital (MGH) by a German chemical firm in return for distribution rights of products resulting from the hospital's findings.
Institutions engaging in DNA research currently comply with voluntary regulations suggested by the NIH, but proponents of the proposed Council regulations have argued that legally binding regulations are needed and have warned of possible threats to public safety if no laws are passed.
David L. Rosenbloom, commissioner of the Boston Department of Health and Hospitals, in a letter to Council President Patrick McDonough after the special committee had revised the proposal, stated that. "It is my firm belief that the ordinance, as amended, provides for an equitable, reasonable, and enforceable regulatory system which will assure that the considerable benefits which may accrue to society through these promising endeavors will be procured in a manner fully protective to the public health and safety."
In the past, representatives of local universities, including Harvard, have agreed that some sort of guidelines are helpful, but have opposed introduction of laws requiring compliance with official regulations, arguing that the universities should be permitted to conduct the research using their own standards.
The proposal, which states that "all use of RDNA by institutions in the city of Boston shall be undertaken only in strict conformity with the [NIH] guidelines," includes the following regulations:
* "timely response to guideline amendments and permit applications in accordance with good governmental practice";
* broadening and restructuring of the Boston Biohazards Committee (BBC)--an area regulatory organization for DNA research--and giving the BBC a larger role in overseeing RDNA research;
* a requirement that institutions engaging in RDNA research monitor the health of their employees and states that the institutions responsibilities in this area should be "reasonable and related to the potential risks" to employees;
* while maintaining the confidentiality of employee health records, the proposal would open up the records for "regulatory or public health study purposes."
In his letter to McDonough, Rosenbloom said that although the potential gains from RDNA research are "enormous and far-reaching," at the same time, "it appears clear that the risks which may be present in this area have yet to be conclusively determined... and as government officials we have a joint responsibility to assure that potential risks... are minimized."