Industrialization of Biology A Roadmap to Accelerate the Advanced Manufacturing of Chemicals (2015) / Chapter Skim
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Appendix B: The Current Regulatory Framework
Appendix B: The Current Regulatory Framework
Pages 125-132
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From page 125... ...
In the next 5 to 10 years, however, it is unlikely that the DNA sequences used to engineer organisms for industrial chemical production will use completely de novo DNA sequences, and thus the regulatory definition is probably sufficient for this stage of industrial biology. At least 90 days prior to manufacturing, importing, or processing a new, inter-generic microorganism for commercial purposes, the responsible firm must submit a complete Microbial Commercial Activity Notice (MCAN)
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From page 126... ...
If the new chemical will be produced by a microorganism intended for release into the environment, such as engineered algae grown in an open-pond system, then the manufacturer would have to conduct field tests prior to submitting the MCAN. Field tests of microorganisms present more uncertainty about health and environmental impacts than field tests of chemicals, because microorganisms can replicate and might proliferate beyond the immediate test site or might transfer genes to related organisms in the wild.
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From page 127... ...
Researchers and administrators from several agencies have extensive experience applying the NIH Guidelines, and industry might be well served to voluntarily adopt these guidelines for testing of industrial microorganisms in contained spaces. Another concern about the EPA's authority under the TSCA and its implementing regulations is that the agency's ability to require safety testing of engineered organisms (or new chemicals)
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From page 128... ...
However, in many instances people affected by an accidental release of an industrial microorganism might have to bring a tort action against the manufacturer, distributor, or other relevant party to obtain environmental cleanup and monitoring. In the event of an accidental or uncontrolled harmful release of industrial microorganisms, the EPA could act under section 6 of TSCA to impose new containment conditions to prevent similar incidents in the future.
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From page 129... ...
, depending on the chemical's intended uses. Under the Plant Protection Act, APHIS regulates the importation, interstate movement, and environmental release of "plant pests," including genetically engineered organisms that might pose a risk to plant health.
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From page 130... ...
When both APHIS and the FDA have jurisdiction over a genetically engineered plant, for instance, if the commercial aim is production of a plant-made pharmaceutical, then APHIS takes the lead in regulating premarket field tests of the engineered plant and the FDA would later subject the plant-made chemical to the premarket approval process typically used for drugs. And, APHIS could share jurisdiction with the EPA if, for example, the engineered organism was a known bacterial plant pest.
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From page 131... ...
If such plants were producing industrial chemicals not intended for a FDA-regulated purpose, then their release into the environment and their commercial distribution would be completely unregulated. Switchgrass engineered for optimal use as a feedstock in biofuel production is an example of a genetically modified plant that did not fall within APHIS's regulatory authority and is otherwise unregulated.
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