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New Biotechnology Products
More on Reviewing New Chemicals
The New Chemicals Program (NCP) is also home to the Toxic Substances Control Act (TSCA) Biotechnology Program. This program is responsible for the safe commercial introduction of new or intergeneric microorganisms with industrial applications, such as bioremediation, or the production of specialty enzymes.
EPA published final rules on Microbial Products of Biotechnology in 1997 that fully implemented its screening program for new microorganisms under Section 5 of TSCA. These regulations create a reporting vehicle specifically designed for intergeneric microorganisms, the Microbial Commercial Activity Notice (MCAN).
The rules also address microorganisms used in research and development for commercial purposes and create a vehicle for reporting on the testing of new microorganisms in the environment, a TSCA Experimental Release Application (TERA). In recognition of the needs of researchers, TERA is designed to provide a high measure of flexibility and a shorter review period.
EPA reviews MCAN and TERA submissions, working closely at times with the submitters, to ensure the microorganisms do not present an unreasonable risk to human health or the environment. Since 1997, EPA has received and reviewed 20 MCANs. Based on review of information provided in the MCANs, EPA determined that these submissions did not warrant regulation because they were not expected to pose an unreasonable risk or have substantial or significant exposure. Since 1997, EPA has also received and approved 20 TERAs.
Accomplishments
- In 2007, EPA received two MCANs for individual microorganisms -- modified Trichoderma reesei strains with enhanced ability to synthesize cellulose-degrading and other enzymes -- as well as one consolidated MCAN covering six different modified organic acid producing microorganisms. EPA determined that these submissions did not warrant regulation and as a result the companies were able to begin commercialization.
- In 2007, EPA received and approved, based on the conditions described by the submitter, one TERA for a modified Pseudomonas putida strain for use in a contained biosensor device for the detection of trichloroethylene in the environment, using bioluminescence.
Read more information on the TSCA Biotechnology Program.