Federal Biotech Regulations Confusing; Diverse Parties Agree on Little Else

A November 30, 2015 story in Bloomberg BNA Daily Environment Report on the federal approach to regulating bioengineered products and comments submitted by nearly a thousand organizations and individuals on the Coordinated Framework for the Regulation of Biotechnology, featured commentary from B&C:

Bergeson & Campbell PC, a law firm that represents companies working with emerging technologies, supported the efforts to update the framework but described structural problems that may thwart the White House’s intentions.

The regulatory infrastructure is ill-suited to address synthetic biology—a new form of genetic engineering—nimbly or comprehensibly, the law firm wrote.

Some synbio products aren’t regulated at all, it wrote.

Exacerbating the problem, it said, are the ‘‘extreme and growing shortages in government staff and funding.’’

Bergeson & Campbell pointed to a report it coauthored recently with the Woodrow Wilson International Center for Scholars’ Synthetic Biology Project as providing insight into fundamental problems federal agencies are facing (200 DEN A-16, 10/16/15).