Bradyrhizobium japonicum Strains: TSCA Experimental Release Applications (TERA) Approval (Fact Sheet)
On March 2, 1999, the Office of Pollution Prevention and Toxics approved the TSCA Environmental Release Applications (TERA) R99-0002 and R99-0003 under the biotechnology regulations promulgated under the Toxic Substances Control Act (TSCA). The TERAs were submitted to modify the submissions R98-0001 through R98-0003.
The modifications are as follows. The microorganism designated as R98-0002, Bradyrhizobium japonicum (B. japonicum) strain Bj 5019, has been removed from the field trials. R98-0001, B. japonicum strain JH359, is now designated R99-0002. R98-0003, B. japonicum strain TN119(12) is now designated R99-0003. In addition, the field trials have been expanded to include 8 small scale sites in Ohio, Wisconsin and Minnesota. The purpose and methods of the field trials are the same as those described in submissions R98-0001 through R98-0003.
Because these microorganisms and their use were already approved under the previous TERA submissions R98-0001 through R98-0003, and the new sites have not changed EPA's risk assessment, the Agency has determined that the new small scale field trials of these intergeneric microorganisms will not present an unreasonable risk of injury to health or the environment. As was done with the previous submissions, the approval letter to the submitter identifies concerns which may be raised if the microorganisms are used on a commercial scale, and lists additional information which may be needed, should the company decide to commercialize one or more of the genetically modified strains. The additional information which may be required for a Microbial Commercial Activity Notice (MCAN) would include: the potential effects of the bacteria on non-target species (plants other than soybean which may host the bacteria); greater detail in the genetic characterization of the strains; detection methods for the microorganisms in the soil; and the benefits of the microorganisms.
For a copy of the original nonconfidential submission and the nonconfidential TERA approval letter, please contact the TSCA Non- Confidential Information Center (NCIC) by phone at (202) 260-7099, or by fax at (202) 260-5069.