Board of Health to move forward with biosafety regulations

  Now that the City Council has approved an ordinance calling for tighter regulations on medical research and life sciences buildings in Revere, it is up to the Board of Health to approve new biosafety regulations for the city.

  At last week’s board meeting, Public Health Director Lauren Buck made an introductory presentation on what biosafety regulations for the city could look like. The regulations will still need to be drafted in conjunction with the city solicitor and go forward to a public hearing before the Board of Health takes a vote on them.

  “The City Council voted a couple of weeks ago to change some of the things on the existing ordinance,” said Buck. The biggest changes in the ordinance are that it limits the biosafety levels that can operate in labs in the city and it places limits on animal testing.

  The updated council ordinance arose from the discussion over the construction of new life sciences facilities at the Suffolk Downs development.

  Under the new ordinance, no life sciences facility can operate at above a biosafety level 2, and animal testing is prohibited from all facilities outside the Suffolk Downs overlay district. Within the overlay district, testing is prohibited on certain animals, including cats, dogs, rabbits and monkeys. Buck said those changes will be incorporated into the new regulations.

  Reviewing regulations from Beverly, Peabody and Bedford, Buck presented an outline of what the Revere regulations might look like. The regulations will include a license application process. “The organizations that will be utilizing the buildings being built in Suffolk Downs will be applying to us for this license,” said Buck. “Any type of biomedical company that wants to go into Suffolk Downs will have to do all of these things.”

  Some of those items on the application process include administrative information, a summary of the recombinant DNA/biological agents being used and how they will be used, the biosafety level and risk designation, a copy of the biosafety manual and copies of the training manual for laboratory staff and the medical surveillance program. The regulations would also require the city to establish an Institutional Biosafety Committee (IBC) to help make recommendations on applications to the Board of Health. The committee would have a member of the local health board or municipal government, as well as a community representative.

  “In terms of their reporting out to us, they are responsible for completing the biosafety level designation and risk assessment,” said Buck.

  The regulations could also provide for the organizations applying for a license to pay for a subject matter expert. “Almost all of the regulations talk about the fact that none of us are experts in biological safety as boards of health; therefore, we will, hopefully, write into our regulations that we also have the ability to have a subject matter expert,” she said. “The cost of the subject matter expert would be associated with the organization.”

  The next steps in the process include the drafting of the regulations with the assistance of the city solicitor, which will then be presented to the Board of Health for review and for a public hearing before potential approval.