Part 725 — Reporting Requirements and Review Processes for Microorganisms
Subpart A — General Provisions and Applicability
Subpart B — Administrative Procedures
- § 725.20— Scope and purpose.
- § 725.25— General administrative requirements.
- § 725.27— Submissions.
- § 725.28— Notice that submission is not required.
- § 725.29— EPA acknowledgement of receipt of submission.
- § 725.32— Errors in the submission.
- § 725.33— Incomplete submissions.
- § 725.36— New information.
- § 725.40— Notice in the Federal Register.
- § 725.50— EPA review.
- § 725.54— Suspension of the review period.
- § 725.56— Extension of the review period.
- § 725.60— Withdrawal of submission by the submitter.
- § 725.65— Recordkeeping.
- § 725.67— Applications to exempt new microorganisms from this part.
- § 725.70— Compliance.
- § 725.75— Inspections.
Subpart C — Confidentiality and Public Access to Information
Subpart D — Microbial Commercial Activities Notification Requirements
- § 725.100— Scope and purpose.
- § 725.105— Persons who must report.
- § 725.110— Persons not subject to this subpart.
- § 725.150— Procedural requirements for this subpart.
- § 725.155— Information to be included in the MCAN.
- § 725.160— Submission of health and environmental effects data.
- § 725.170— EPA review of the MCAN.
- § 725.190— Notice of commencement of manufacture or import.
Subpart E — Exemptions for Research and Development Activities
- § 725.200— Scope and purpose.
- § 725.205— Persons who may report under this subpart.
- § 725.232— Activities subject to the jurisdiction of other Federal programs or agencies.
- § 725.234— Activities conducted inside a structure.
- § 725.235— Conditions of exemption for activities conducted inside a structure.
- § 725.238— Activities conducted outside a structure.
- § 725.239— Use of specific microorganisms in activities conducted outside a structure.
- § 725.250— Procedural requirements for the TERA.
- § 725.255— Information to be included in the TERA.
- § 725.260— Submission of health and environmental effects data.
- § 725.270— EPA review of the TERA.
- § 725.288— Revocation or modification of TERA approval.
Subpart F — Exemptions for Test Marketing
Subpart G — General Exemptions for New Microorganisms
- § 725.400— Scope and purpose.
- § 725.420— Recipient microorganisms.
- § 725.421— Introduced genetic material.
- § 725.422— Physical containment and control technologies.
- § 725.424— Requirements for the Tier I exemption.
- § 725.426— Applicability of the Tier I exemption.
- § 725.428— Requirements for the Tier II exemption.
- § 725.450— Procedural requirements for the Tier II exemption.
- § 725.455— Information to be included in the Tier II exemption request.
- § 725.470— EPA review of the Tier II exemption request.
Subpart L — Additional Procedures for Reporting on Significant New Uses of Microorganisms
- § 725.900— Scope and purpose.
- § 725.910— Persons excluded from reporting significant new uses.
- § 725.912— Exemptions.
- § 725.920— Exports and imports.
- § 725.950— Additional recordkeeping requirements.
- § 725.975— EPA approval of alternative control measures.
- § 725.980— Expedited procedures for issuing significant new use rules for microorganisms subject to section 5(e) orders.
- § 725.984— Modification or revocation of certain notification requirements.
Subpart M — Significant New Uses for Specific Microorganisms
- § 725.1000— Scope.
- § 725.1075— Burkholderia cepacia complex.
- § 725.1079— Arsenic detecting strain of E. coli with extra-chromosomal elements, including an intergeneric screening marker (generic).
- § 725.1080— Trichoderma reesei (generic).
- § 725.1081— Trichoderma reesei modified (generic).
- § 725.1082— Microorganism expressing enzymes (generic).