Biotech companies `flash a thumbs-up' on US guidelines. Industry says rules clarify, but critic calls them rubber stamps
Biotechnology companies announced late last week that they support new federal guidelines established to govern their industry. While it isn't often that an industry invites government action, biotech firms say the guidelines are needed to clarify existing regulations and to assure the public that the environment is being properly protected.
``We want to flash a thumbs-up to the regulatory agencies who are involved,'' says Richard D. Godown, executive director of the Industrial Biotechnology Association (IBA). ``We are pleased with the effort; we think it is a significant, substantial step forward.''
The IBA released its comments after an intensive, three-month study. Along with its support, IBA offered a few refinements to improve definitions, providing for some exemptions, and revising proposals by the United States Department of Agriculture (USDA). Sources close to the regulatory process indicated that IBA's suggestions are ``in the ballpark'' of acceptable changes. Several federal agencies have jurisdiction over the biotechnology industry, depending on the product. A new pesticide would be covered by the Environmental Protction Agency (EPA), a new plant species or animal vaccine by the USDA, and new food-processing techniques or new medicines by the Food and Drug Administration (FDA). Regulating biotech products did not require new laws. A number of statutes provides the basis for federal jurisdiction, even though biotechnology was barely known when the laws were passed.
It was precisely this array of laws that caused concern in the young industry. With the double burden of fierce international competition and the enormous up-front research costs, the industry warned Washington that it was becoming mired in regulatory quicksand. Not wanting to hamper what experts concede will be a multibillion-dollar industry, the White House acted quickly. A working group was established within the cabinet in the spring of 1984. For two years the EPA, USDA, FDA, and several other federal agencies worked out a coordinated system of regulation. For industry, it was simply a question of putting a very fuzzy picture of federal regulations into focus.
The working group came up with a framework outlining the basic policies and procedures of the federal agencies with biotech jurisdiction. Categories of genetically engineered organisms deemed risky enough to require regulation were established, and an expedited review system for products with less concern was set up. According to the White House, they were developed ``with special attention to fostering a rational, integrated regulatory structure that is neither unduly burdensome nor carelessly incomplete.''
Biotech watchdog Jeremy Rifkin has filed suit in federal court to prevent the guidelines from taking effect. He is concerned about what microbes created in the laboratory might do once released into the environment. ``The fact that [the industry] is comfortable with these guidelines should suggest to all of us what is really going on here,'' Mr. Rifkin said when the guidelines came out. ``These guidelines are industry guidelines, rubber stamped by the Reagan administration, . . . environmental concerns are totally absent.''
David T. Kingsbury, who headed the White House working group, denies there was any direct industry input or that there is any threat to public safety. ``The fact is, much of the scientific community thinks we are over zealous,'' Dr. Kingsbury says.