The Reagan administration will soon release a new set of regulations to oversee the burgeoning biotechnology industry. The industry says the new rules are needed to replace the current maze of regulations now hobbling biotechnology companies. Critics claim the new guidelines ignore environmental concerns and are nothing more than a rubber stamp of corporate desires for deregulation. The biotechnology industry has appeared on the scene so quickly that the federal government found itself struggling to keep up with it. The pace of scientific discoveries in biotechnology has strained the government's capacity to oversee new research. The industry holds potential to improve agricultural crops, develop new medicines, and a host of other products. Experts say, however, that this potential must be balanced with concerns associated with releasing genetically engineered organisms into the environment.
``Let's think about where the industry is right now. They are paralyzed, absolutely paralyzed,'' says Dr. David T. Kingsbury, who heads a White House working group on biotech policy. ``For the last three years some of the regulatory agencies have been afraid to handle any applications.''
None of the laws generated to oversee the introduction of new products into the marketplace anticipated genetic engineering. This new field enables scientists to ``map'' the genetic structure of a plant, animal or microorganism and manipulate that structure to achieve new characteristics. Current projects include vaccines and diagnostic tests, the creation of crops that are insect- or frost-resistant, and bacteria that will ``eat'' its way through clogged drains.
Companies seeking to submit applications for government approval for the testing and introduction of biotech products are faced with dozens of potentially relevant laws and several federal agencies. Not all agencies agree on what regulations govern any particular product, and more than one ``turf battle'' has erupted among the agencies.
Dr. Kingsbury heads the White House working group that has drafted the new regulations after several years of interagency negotiation. He is confident that the new rules protect the public interest while at the same time giving industry clear directions on how to get their products approved.
Critics disagree. Jeremy Rifkin, longtime biotech critic and president of the Foundation on Economic Trends, is appalled at the new guidelines and plans to file suit this week to halt their implementation.
``The White House has rubber stamped the industry's request and basically said to the American public that they don't care about the environment. [They] ignored public concern, they ignored the mounting concern in Congress, and they deregulated an entire technology before there were even regulations in place that could maintain some kind of public health and safety standards,'' according to Mr. Rifkin.
He also points out that there is no insurance for the biotech industry. Insurance companies, he claims, won't touch the industry because the risks are too incalculable. ``If one microbe experiment runs wild and causes a problem comparable to something like chestnut blight did, we are talking about hundreds of millions of dollars in damage extended over generations,'' Rifkin estimates.
Dr. Kingsbury contends that experts do not agree with Rifkin. ``What he is really saying is, `Can we, based on a broad body of evidence, predict how any microbe is going to behave in the environment?' That really is a separate issue from, `Can we assess the behavior of a specific product?' The answer is, on a case-by-case basis, we can do it. . . . The fact is, much of the scientific community thinks that we [the government] are overzealous.''
The White House is eager to preserve US leadership in biotechnology. A conducive regulatory climate is a vital component of that leadership, along with continued federal support of basic and applied research and an innovative private sector. According to the White House, the new rules were developed ``with special attention to fostering a rational, integrated regulatory structure that is neither unduly burdensome nor carelessly incomplete.''