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| EPA/OCSPP | RIN: 2070-AJ65 | Publication ID: Fall 2011 |
| Title: Microorganisms: General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions | |
| Abstract: In 1997, EPA promulgated a final rule under section 5 of Toxic Substances and Control Act (TSCA) to establish the notification procedures for review of certain new microorganisms before they are introduced into commerce. "New" microorganisms are those formed by deliberate combinations of genetic material from organisms classified in different taxonomic genera. This review process is designed to prevent unreasonable risk of injury to human health and the environment without imposing unnecessary regulatory burdens on the biotechnology industry. The rule also established TSCA section 5(h)(4) exemptions from full reporting when 10 specific microorganisms are used as the recipient microorganisms for the introduced genetic material and placed requirements on these recipient microorganism, the introduced genetic material, and the physical containment (40 CFR 725, subpart G). The rule also established a mechanism (40 CFR 725.67) for the public to petition the Agency to propose additional recipient microorganisms for such exemptions. These regulations describe the appropriate supporting information that must be submitted with the petition to provide EPA with a starting point for determining whether the recipient should be listed as a candidate for the tiered exemption. EPA has received petitions to add two additional microorganisms to the eligible recipient microorganisms listed in 40 CFR 725.420 (Trichoderma reesei and Bacillus amyloliquefaciens). EPA is evaluating the information provided in these petitions. If, as result of this evaluation, EPA makes a preliminary determination that one or both of the two microorganisms will not present an unreasonable risk of injury to health or the environment, then EPA will propose a rule to grant the exemption petition for that microorganism(s). | |
| Agency: Environmental Protection Agency(EPA) | Priority: Substantive, Nonsignificant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: 15 USC 2601 et seq | |
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Legal Deadline:
None |
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Timetable:
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| Additional Information: SAN No. 5418 | |
| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Small Entities Affected: No | Federalism: No |
| Included in the Regulatory Plan: No | |
| RIN Information URL: http://www.epa.gov/oppt/ | |
| Sectors Affected: 325 Chemical Manufacturing | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Brian Lee Environmental Protection Agency Office of Chemical Safety and Pollution Prevention 7405M, Washington, DC 20460 Phone:202 564-6293 Email: lee.brian@epa.gov Greg Schweer Environmental Protection Agency Office of Chemical Safety and Pollution Prevention 1200 Pennsylvania Avenue NW, Mail Code 7405M, Washington, DC 20460 Phone:202 564-8469 Fax:202 564-9094 Email: schweer.greg@epa.gov |
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