Study Says State Needs Rules for Biotech Firms

A yearlong study by the state Assembly concludes that, while California is home to more than a third of the 200 biotechnology companies in the United States, the state’s regulatory agencies are completely unprepared to oversee the burgeoning industry and make sure it is safe.

The study, prepared by the Assembly’s Committee on Economic Development and New Technologies and released Tuesday, concludes that biotechnology as an industry is “safe” and that federal and state laws adequately cover its regulation.

But the committee found that, while federal agencies have prepared and coordinated specific regulatory policies according to law, California agencies have no such policy. This leaves companies in California without a clear idea of which agency governs which area of biotechnology, the report says.

‘Haven’t Thought About It’

“The laws are there,” said Assemblyman Sam Farr (D-Santa Cruz/Monterey), who is chairman of the committee. “But the state agencies don’t know what they are and haven’t thought about it. They just haven’t thought about the (biotech) industry.”

Farr said the report recommends that agencies such as Water Resources, the Department of Health Services and the Department of Agriculture develop their own policy and guidelines to regulate biotechnology and that the governor’s office set up a task force by the end of the year to review and coordinate the plans.

The report recommends that the state Legislature pass legislation to coordinate the policies if the governor fails to act within seven months.

The state Assembly last year called on the committee to study how to “promote the (biotechnology) industry while at the same time protecting public health and safety and the environment.”

The committee’s aim was to assess the industry, “find out what’s out there” and then come up with a plan to formulate state regulation without duplicating federal efforts or embroiling the fledgling industry with “unnecessary red tape,” Farr said.