Title 40, Part 725 — Reporting Requirements and Review Processes for Microorganisms

Scope and purpose.

Definitions.

Coverage of this part.

Identification of microorganisms for Inventory and other listing purposes.

Determining applicability when microorganism identity or use is confidential or uncertain.

Consultation with EPA.

Scope and purpose.

General administrative requirements.

Submissions.

Notice that submission is not required.

EPA acknowledgement of receipt of submission.

Errors in the submission.

Incomplete submissions.

New information.

Notice in the Federal Register.

EPA review.

Suspension of the review period.

Extension of the review period.

Withdrawal of submission by the submitter.

Recordkeeping.

Applications to exempt new microorganisms from this part.

Compliance.

Inspections.

General provisions for confidentiality claims.

Uses of a microorganism.

Public file.

Scope and purpose.

Persons who must report.

Persons not subject to this subpart.

Procedural requirements for this subpart.

Information to be included in the MCAN.

Submission of health and environmental effects data.

EPA review of the MCAN.

Notice of commencement of manufacture or import.

Scope and purpose.

Persons who may report under this subpart.

Activities subject to the jurisdiction of other Federal programs or agencies.

Activities conducted inside a structure.

Conditions of exemption for activities conducted inside a structure.

Activities conducted outside a structure.

Use of specific microorganisms in activities conducted outside a structure.

Procedural requirements for the TERA.

Information to be included in the TERA.

Submission of health and environmental effects data.

EPA review of the TERA.

Revocation or modification of TERA approval.

Scope and purpose.

Persons who may apply under this subpart.

Procedural requirements for this subpart.

Information to be included in the TME application.

EPA review of the TME application.

Scope and purpose.

Recipient microorganisms.

Introduced genetic material.

Physical containment and control technologies.

Requirements for the Tier I exemption.

Applicability of the Tier I exemption.

Requirements for the Tier II exemption.

Procedural requirements for the Tier II exemption.

Information to be included in the Tier II exemption request.

EPA review of the Tier II exemption request.

Scope and purpose.

Persons excluded from reporting significant new uses.

Exemptions.

Exports and imports.

Additional recordkeeping requirements.

EPA approval of alternative control measures.

Expedited procedures for issuing significant new use rules for microorganisms subject to section 5(e) orders.

Modification or revocation of certain notification requirements.

Scope.

Burkholderia cepacia complex.

Arsenic detecting strain of E. coli with extra-chromosomal elements, including an intergeneric screening marker (generic).

Trichoderma reesei (generic).

Trichoderma reesei modified (generic).

Microorganism expressing enzymes (generic).