Regulacje i polityka gospodarcza · 5.09.2012

Microorganisms; General Exemptions From Reporting Requirements; Revisions to Recipient Organisms Eligible for Tier I and Tier II Exemptions

EPA received petitions to add Trichoderma reesei and Bacillus amyloliquefaciens to the list of microorganisms that may be used as recipient microorganisms in order to qualify for the exemption from full notification and reporting procedures under the Toxic Substances Control Act (TSCA) for new microorganisms that are being manufactured for introduction into commerce. Based on EPA's evaluation of these petitions, EPA has made a preliminary determination that certain strains of both microorganisms will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism provided that certain criteria for the introduced genetic material and the physical containment conditions are met. Therefore, EPA is proposing to add two additional microorganisms to the list of recipient microorganisms that are eligible for exemptions from full reporting for the manufacture (including import) of new microorganisms.