On July 31, 2002, the Office of Pollution Prevention and Toxics approved the TSCA Environmental Release Application (TERA) under the biotechnology regulations promulgated under the Toxic Substances Control Act (TSCA). The TERA, submitted by Micro Systems Technologies, LLC, involves field trials of a modified strain of Pseudomonas fluorescens. The TERA was given the tracking designations of R-02-0001. The microorganism has been genetically modified to contain a bioluminescent gene that is activated upon metabolism of naphthalene and/or methyl salicylate. Field trials will be conducted to demonstrate the effectiveness of the TERA in detection and quantification of napthalene and methyl salicylate for eventual commercial scale detection applications. Seventy-two tests are scheduled over a period of one year beginning in August 2002.

Regulatory Background

The EPA requirements concerning microbial products subject to TSCA (15 U.S.C. Section 2601, et seq.) are set forth in “Microbial Products of Biotechnology; Final Regulation under the Toxic Substances Control Act” (62 FR 17910 (April 11, 1997)) and codified at 40 C.F.R. Part 725. Microorganisms resulting from the deliberate combination of genetic material originally isolated from organisms of different taxonomic genera (intergeneric microorganisms) constitute “new” microorganisms subject to TSCA Section 5 notification requirements. Persons who manufacture, import, or process intergeneric microorganisms for commercial purposes subject to EPA jurisdiction under TSCA, are required to submit a Microbial Commercial Activity Notice (MCAN). Persons conducting commercial research and development activities may submit a TERA, instead of an MCAN, before initiation of such testing. EPA conducts a review of these submissions to determine whether the intergeneric microorganisms present an unreasonable risk to health or the environment. The Agency can impose regulatory controls under section 5 of TSCA.

Summary of the Risk Assessment

P. fluorescens is commonly found in the environment in soil, water, and plants. There are instances of opportunistic pathogenicity in plants and animals but no data for frank pathogenicity. The genetic modifications involved in creating the TERA strain are not expected to confer properties of toxigenicity or pathogenicity. Further, the microorganisms will be contained in a sampling device. Because of the low potential exposure, there is low risk associated with the field test.

Conclusion

EPA has determined that the proposed small scale field trials of the intergeneric microorganism will not present an unreasonable risk of injury to health or the environment. In the TERA approval letter, EPA advised the submitter to avoid the use of antibiotic resistance markers that are associated with clinically significant antibiotics, and to avoid the use of a mobile genetic element.

For a copy of the original nonconfidential TERAs and the nonconfidential approval letter, please contact the TSCA Non-Confidential Information Center (NCIC) by phone at (202) 566-0280, or by fax at (202) 566-9744.