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The U.S. Environmental Protection Agency (EPA; Washington, D.C.; www.epa.gov) is proposing to add two microorganisms (specific strains of the fungus Trichoderma reesei and specific subspecies of the bacterium Bacillus amyloliquefaciens) to the list of ten recipient microorganisms that are eligible for exemptions from full chemical notification requirements under the Toxic Substances Control Act (TSCA). EPA will take comment on the proposal until November 5, 2012.
EPA regulations for implementing its review program for new intergeneric microorganisms under section 5 of the TSCA define a number of exemptions and codify EPA’s approach to research and development for microbial products of biotechnology. These rules are designed to ensure that EPA can adequately identify and regulate risk associated with microbial products of biotechnology.
Microorganisms subject to this rule are “new” microorganisms used commercially for TSCA purposes, such as production of industrial enzymes and other chemicals; agricultural practices; biosensors; production of biofuels, and break-down of chemical pollutants in the environment. According to EPA’s rule, new microorganisms are those “intergeneric” microorganisms (including bacteria, fungi, algae, viruses, protozoa, etc.) formed by combining genetic materials from organisms in different genera. EPA believes that intergeneric microorganisms have a sufficiently high likelihood of expressing new traits or new combinations of traits to be termed “new” and warrant review.
Microorganisms that are not intergeneric are not considered “new” and, thus, are not subject to reporting under section 5 of TSCA. When defining “intergeneric microorganism,” in the case of chemically synthesized genes, the Agency has followed a similar principle. The genetic sequence of the synthesized gene may be identical to a sequence known to occur in an organism in the same genus as the recipient microorganism. If so, the resulting microorganism is considered intrageneric and, thus, is not new. Conversely, the sequence of the synthesized gene may be different or not know to be identical to a sequence in the genus of the recipient microorganism, in which case, the resulting product is considered intergeneric. EPA strongly encourages any manufacturer of a new microorganism using synthetic DNA to contact the Agency.
The TSCA section 5 notification specifically required for microorganisms is the Microbial Commercial Activity Notice (MCAN). Persons intending to manufacture or import intergeneric microorganisms for commercial purposes in the U.S. must submit a MCAN to EPA at least 90 days before such manufacture or import. EPA has 90 days to review the submission in order to determine whether the intergeneric microorganism may present an unreasonable risk to human health or the environment. If EPA makes that determination, EPA may impose appropriate regulatory restrictions.
The regulations also cover intergeneric microorganisms used in R&D for commercial purposes. The TSCA section 5 notification required for R&D testing of new microorganisms that are released in the environment is the TSCA Experimental Release Application (TERA). A TERA must be submitted to the EPA at least 60 days prior to initiating such field trials.
EPA’s biotechnology rule contains several exemptions from the requirement to submit a MCAN, if the manufacturer meets criteria defining eligible microorganisms and specified use conditions. Exemptions for R&D are included. There is an R&D exemption for activities conducted inside a structure and outside a structure. A test market exemption is provided in subpart F. Subpart G provides two exemptions limited to specified recipient microorganisms and introduced genetic material that is limited in size, well-characterized, poorly mobilizable, and free of certain sequences. The “Tier I” exemption requires certain certifications and record keeping while the “Tier II” exemption requires certain certifications and a notification to EPA and Agency review of specific physical containment and control technologies.