Text of Press Release for Microbial Products of Biotechnology: Biotechnology Final Rule (March 27, 1997)

Headquarters Press Release
Washington, DC
Date: 03/27/97

Published: 03/27/97
Title: PR NEW NOTIFICATION AND SCREENING REQ. FOR BIOTECH PRODUCTS

PR NEW NOTIFICATION AND SCREENING REQ. FOR BIOTECH PRODUCTS
FOR RELEASE: THURSDAY, MARCH 27, 1997

EPA Issues New Notification and Screening Requirements for Biotech Products

The U.S. Environmental Protection Agency is issuing new regulations that establish a streamlined process for the screening of certain microbial biotechnology products to ensure that they are safely developed for commercial use in a broad range of industrial and environmental applications. The new regulations are being issued under the Toxic Substances Control Act (TSCA).

"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," said EPA Administrator Carol M. Browner. "Our goal is to help the nation safely realize the widespread benefits of biotechnology in a number of markets, from pollution prevention to environmental cleanup."

The regulations cover those microbial biotechnology products developed for industrial applications subject to EPA oversight under TSCA. Other federal authorities regulate the development and introduction of biological pesticides, drugs and food additives.

Under these regulations, companies that manufacture or researchers who develop microbial biotechnology products are required to notify and obtain EPA review prior to the use of their products in commerce or testing in the environment. Specifically the new regulations:

• Tailor pre-existing screening requirements for new chemicals and establish a distinct program for microbial biotechnology products under section 5 of TSCA. EPA has been reviewing microbial biotechnology products for 10 years under the authority of a policy statement issued in 1986 and under TSCA regulations originally written for new chemicals. Today's action supersedes these pre-existing policies and regulations.
• Continue to focus the Agency's regulatory attention on microorganisms that are likely to display new traits or to exhibit less predictable behavior in the environment.
• Provide full or partial exemptions from the notification and screening requirements for certain categories of new microorganisms introduced for commercial use or testing in the environment and for which EPA has acquired substantial assessment experience. A process for seeking additional exemptions also is provided.

The final rule is expected to be published in the Federal Register April 11. The text of the final rule and certain support documents also will be made available electronically upon the date of publication in the Federal Register. These documents may be accessed through the Office of Pollution Prevention and Toxic's Biotechnology Program homepage.