Regulatory Policy and Bioremediation: Implications for DOE’s Cleanup. D. J. Bjornstad and A. K. Wolfe, Oak Ridge National Laboratory
The Department of Energy carries out bioremediation research intended to develop new ways to use microorganisms for treating and remediating DOE legacy wastes. The current focus is on immobilization strategies, coupled with long-term stewardship programs. To find use, these technologies must meet the requirements of the regulatory process. This paper focuses on the regulatory process as it is applied to the products of biotechnology. The paper provides an overview existing regulatory requirements, suggests the manner in which these requirements will be applied to the DOE cleanup, and identifies aspects of legacy waste bioremediation that may not fall under the purview of existing regulatory practices.
A unique aspect of the DOE cleanup is its application of RCRA and CERCLA within the context of a long-term staged action plan, recorded in CERCLA records of decision and bound legally through compliance agreements governed by the Federal Facilities Compliance Act. These elements, coupled with an undemonstrated long-term stewardship program, present a significant challenge to bioremediation proponents. They must typically reopen past decisions, substitute bioremediation for a more familiar and proven technology, convince regulators that over time risk management can be effected through long-term stewardship.
The paper lays the foundation for future recommendations about information that likely will be required in the regulatory process. Identifying These potentially unique information needs now will allow the required information to be collected during the course of DOE bioremediation research. While stopping short of identifying these information needs, the paper proposes criteria for meeting risk-based regulatory requirements.
Go to . . .
2002 SRA Annual Meeting Table of Contents
2002 SRA Annual Meeting Author Index
Main Abstracts Menu Page
RiskWorld Home Page