| Overview of Regulations & Purpose
of Form |
| |
While many permits are common to all businesses, biotechnology research
and development requires a specific city permit. This City of Cambridge
permit process must be completed prior to the initiation of research that
uses rDNA technologies and requires that companies form an Institutional
Biosafety Committee (IBC) as the internal mechanism of research oversight
and the point of contact for the City of Cambridge Biosafety Committee
(CBC).
The local recombinant DNA Ordinance was enacted in 1976 following the
then prevalent concerns regarding possible health and safety issues resulting
from the generation and release of recombinant DNA microorganisms. The
City of Cambridge rDNA Ordinance is based on the National Institute of
Health Guidelines for Research Involving Recombinant DNA Molecules (April
2002) but with one difference. The local ordinance does not recognize
any rDNA based research as exempt from the need for permitting through
the CBC or from registration with the internal IBC. Biotechnology companies
proposing to utilize rDNA based biological research are expected to conform
to all requirements of the local City of Cambridge ordinance (Chapter
8.20 Recombinant DNA Technology). Companies should apply for a Recombinant
DNA Permit through the Cambridge Public Health Department (CPHD). The
Cambridge Biosafety Committee, managed through the CPHD, is charged with
the responsibility for review and approval of rDNA permits and research
facilities.
There are multiple steps in the rDNA permitting process. One of the first
steps is formation of a company Institutional Biosafety Committee. This
internal IBC is meant to provide both peer and public review and approval
and should have the appropriate scientific expertise as well as representatives
of the Cambridge community. Appropriate scientific expertise is essential
to ensure adequate review and biosafety assessment of the proposed research.
The Cambridge resident members are present to ensure the views and concerns
of the community are expressed and addressed during the internal review
and approval process. The membership and contact information of the IBC
must be submitted to the CBC as part of the permit application package.
The general scope and membership of the IBC is meant to conform to the
section IV-B of the NIH rDNA Guidelines (April 2002).
Besides formation of an Institutional Biosafety Committee, companies/applicants
must complete the permit application form, must submit a copy of the company’s
Health and Safety Manual, an outline of the proposed safeguards and procedures,
a description of the training program for personnel using rDNA technologies,
a list of principal investigators and the research locations they control
for rDNA use, as well as a list of the Biosafety Containment levels for
the various research areas (see the NIH rDNA Guidelines and the CDC/NIH
Biosafety in Microbiological and Biomedical Laboratories, 4th edition,
1999).
The CBC utilizes this information as well as a facility inspection prior
to the commencement of any regulated work as part of the evaluation and
approval process. |
