Online Program

Local regulation of laboratory biosafety in cambridge, Massachusetts

Wednesday, November 6, 2013 : 9:06 a.m. - 9:18 a.m.

Sam Lipson, MS, REHS, Cambridge Public Health Department, City of Cambridge (MA), Cambridge, MA
Susan Woskie, PhD, C.I.H., Occupational & Environmental Hygiene Program and Biological & Laboratory Safety Certificate, University of Massachusetts Lowell, Lowell, MA, MA
Cambridge, Massachusetts (pop. 105,000) has emerged within the past 30 years as the most active global center of innovation in biotechnology, genetically-based clinical therapeutics, and pharmaceutical product development. Beyond Harvard and MIT, Cambridge regulates 80+ firms and institutions engaged in biological research and manufacturing that may pose public health risk to employees and neighbors. The current general acceptance of the biotech sector and academic biological research within this community, well known for skepticism towards institutional assurances, only emerged after intense debate over the ethical and public health implications of genetically altered organisms in the 1970s.

Concerns about lab-acquired infections and environmental releases of genetically altered viruses and bacteria were addressed with enactment of local regulations intended to assure residents and workers that all work meets standards established by the National Institutions of Health ("Guidelines for Research Involving Recombinant DNA Molecules"). These locally enforceable guidelines classify microorganisms and their specific gene insertions by Risk Group and impose biosafety containment levels (BSLs) according to the potential risk associated with that work. The Cambridge Public Health Department coordinates a citizens' committee charged with oversight of all laboratories engaged in regulated biological work. Biosafety training workshops are conducted to train residents willing to serve as community representatives on internal biosafety committees for each institution or company, to train public health professionals, and to provide training for biosafety officers within each permitted establishment. This presentation will offer an overview of enforcement and public engagement strategies required for public assurance regarding biological research and manufacturing.

Learning Areas:

Occupational health and safety
Other professions or practice related to public health
Protection of the public in relation to communicable diseases including prevention or control
Public health or related laws, regulations, standards, or guidelines
Public health or related organizational policy, standards, or other guidelines

Learning Objectives:
Describe a program of enforcement and education to establish local oversight of laboratory biosafety within the commercial biotech sector and academic biological laboratories.

Keyword(s): Regulations, Safety in Labs

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am the primary official responsbile for enforcement of the Recombinant DNA Technology Ordinance and the Cambridge Laboratory Biosafety Regulation within the City of Cambridge, MA. I have conducted laboratory inspections, coordinated the citizen advisory committee, organized and presented at recurring biological safety forums for 15 years. I have advised public health professionals and community groups on potential risk associated with biological labs and have proposed innovative approaches for local, community-based regulation of biological safety.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.