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EPA/OCSPP | RIN: 2070-AJ65 | Publication ID: Fall 2015 |
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 established a mechanism (40 CFR 725.67) for the public to petition the Agency to propose additional recipient microorganisms for such exemptions. Those regulations also described 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 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 TSCA for new microorganisms that are being manufactured (defined by statute to include import) for introduction into commerce. Based on EPA's evaluation of these petitions, EPA 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 and issued a proposed rule. After considering comments on its proposed exemption, EPA is developing a revised proposal that will address the concerns raised by the commenters. |
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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: 40 CFR 725 | |
Legal Authority: 15 U.S.C. 2605 Toxic Substances Control Act |
Legal Deadline:
None |
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Timetable:
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Additional Information: Docket #: EPA-HQ-OPPT-2011-0740 | |
Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Information URL: http://www2.epa.gov/chemicals-under-tsca | Public Comment URL: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2011-0740-0001 |
Sectors Affected: 325 Chemical Manufacturing | |
RIN Data Printed in the FR: No | |
Agency Contact: 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 |