By Lisa Seachrist
The Environmental Protection Agency is issuing new regulations to streamline the screening process for microbial biotechnology products for use in commercial applications.
The new regulations, which are being issued under the Toxic Substances Control Act (TSCA), will be published in the Federal Register on April 11 and mark the end of a decade-long process to develop a regulatory framework for microbial biotech products designed for industrial or environmental use.
"Today's action achieves the Clinton Administration's objective to protect human health and the environment while providing flexibility for the development of our nation's emerging biotechnology industry," EPA administrator Carol Browner said in a statement.
The regulations apply to microbial biotechnology products subject to EPA oversight under the TSCA, such as microbially derived enzymes for improved laundry detergents as well as bacteria developed to clean up contaminated soil and water.
"We have been working on this since 1983," said Alan Goldhammer, director of technical affairs for the Biotechnology Industry Organization (BIO). "The regulation will formalize the EPA's approach. However, we have yet to read the rules to see if the agency took any of our suggestions."
The new regulations establish a distinct program to review microbial biotechnology products that aren't used as pesticides or regulated by FDA for use as drugs and food additives. For the past 10 years, the agency has been reviewing these products under the authority of a policy statement issued in 1986 and under the TSCA regulations originally written for new chemicals. The new policies will supersede these former regulations.
"These regulations don't cover a great many biotech products at the moment," Goldhammer said. "But one day they could, if companies start to use biotechnology to manufacture industrial chemicals."
All companies using microbial biotech products are required to notify the EPA and obtain review prior to commercial use of their products or testing in the environment. The agency published a proposed rule in the Federal Register in late 1994 in an attempt to streamline the procedure and establish which types of products are exempted from the regulation. Goldhammer said that BIO submitted extensive comments to those rules in 1995.
At the time, BIO was concerned about the TSCA exemption for materials used for research and development from regulation. "There has been a broad exemption for research reagents, including the ability of companies to sell reagents as long as they are marked for research only," Goldhammer said. "There was some concern whether biotech products such as laboratory reagents are exempt. Our position is that they should be exempt."
In addition, BIO's comments addressed a broader issue of the use of genetically engineered microorganisms in the environment for research. The agency had developed a schema to examine these organisms at early, stage research because it was felt that because the microorganisms can multiply, putting them into the environment was somehow different from putting a new chemical into the environment.
"We suggested a separate way of looking at those types of microorganisms from the schema that they developed," Goldhammer said. "Again, until the final rules are published we won't know how the agency ultimately decided the issue."
In its proposed rules, the agency also proposed a commercial use exemption for some relatively low risk fermentation processes.
"We are looking in the final rule for the two-tiered exemptions," Goldhammer said. "Depending on how it was structured, it could mean that there is a lesser burden on industry because some things would be completely exempt."
Goldhammer offered the example of a company that had developed a new fermentation process for the production of a laundry enzyme in a certain type of organism. It is possible that those types of products would be completely exempt from regulation if the companies followed specific containment procedures.
Goldhammer said that BIO intends to take a long hard look at the final rules when they are published to see if they achieve the agency's stated goal of continuing to focus regulatory attention on microorganisms that are likely to display new traits or to exhibit less predictable behavior in the environment.
"These rules may provide clarity on some of the issues," Goldhammer said. "But we will see in April." *