Microorganisms exemptions

I have included in today s presentation three of these issues first, the distinction between a "new" and a "naturally occurring" chemical substances for the purpose of the applicability of the premanufacture notification (PMN) requirement of TSCA second, the scope of the research and development exemption from the PMN requirements, and its implication for open field testing of microorganisms and third the type and amount of information that EPA might need for risk/benefit analyses of new microorganisms. I will also briefly mention some technical areas in which further research would greatly facilitate the processes of risk/benefit assessment. 

There is no fee for filing TME applications, LVEs, or LoREXs or exemptions from the microorganism regulations. 

There is an R D exemption for microorganisms, but it is substantially different in recognition of the fact that living organisms pose unique regulatory... 

The EPA receives very few MCANs each year. In 2007 it received three MCANs covering eight microorganisms, and just one TERA." Only 43 intergeneric microorganisms have been added to the Inventory through the MCAN process." In contrast, in the 18 months covering 2007 and the first half of 2008, 1071 PMNs and 630 applications for low volume exemptions from the PMN requirements were filed."... 

See Chapter 8, Exports and Imports. Microorganisms were specifically exempted from the 2006 Inventory Update Rnle. See Chapter 3, The Inventory. 

There are several exemptions from the MCAN requirements for microorganisms made or imported solely for research and development. If there is no intentional testing outside of a structure the microorganism is exempt if another federal agency requires compliance with National Institutes of Health Guidelines, or if the research and development is performed under the supervision of a technically qualified individual and there are controls in place to contain or inactivate the microorganisms and involved individuals are notified of certain specified health risks. ... 

Microorganisms that qualify for a Tier 1 exemption are exempt from the MCAN requirements. Tier 1 applies when the recipient organism is one of ten specifically listed microorganisms and if it is the recipient of specific types... 

C.F.R. jtjt 725.1, 725.110 and 725.300. Only one test marketing exemption has been approved for a microorganism. See http //www.epa.gov/biotech rule/pubs/submain.htm. 

The Tier II exemption is an expedited, 45 day review for certain microorganisms. Microorganisms qualify for a Tier II exemption if the recipient organism is one of the same ten that qualify for the Tier I exemption, and has only the types of added genetic material permitted for the Tier I exemption. There must be some containment and physical controls, but they do not need to reach the level of the containment and physical controls for a Tier I exemption the regulations require only that they be adequate. A Tier II exemption request must be submitted at least 45 days before the first manufacture or import. EPA may approve the request with or without conditions, and it may deny the request. If EPA denies the request the submitter may submit an MCAN. 

In addition, any microorganisms that are exempt from the statutory definition of chemical substances are exempt from all the TSCA requirements, and these include... 

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