Part 725 - Reporting Requirements and Review Processes for Microorganisms  


Subpart A - General Provisions and Applicability
§ 725.1 - Scope and purpose.
§ 725.3 - Definitions.
§ 725.8 - Coverage of this part.
§ 725.12 - Identification of microorganisms for Inventory and other listing purposes.
§ 725.15 - Determining applicability when microorganism identity or use is confidential or uncertain.
§ 725.17 - Consultation with EPA.
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
§ 725.80 - General provisions for confidentiality claims.
§ 725.85 - Microorganism identity.
§ 725.88 - Uses of a microorganism.
§ 725.92 - Data from health and safety studies of microorganisms.
§ 725.94 - Substantiation requirements.
§ 725.95 - Public file.
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
§ 725.300 - Scope and purpose.
§ 725.305 - Persons who may apply under this subpart.
§ 725.350 - Procedural requirements for this subpart.
§ 725.355 - Information to be included in the TME application.
§ 725.370 - EPA review of the TME application.
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.
Subparts H--K - XXX
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 - xxx
§ 725.1080 - xxx
§ 725.1081 - Trichoderma reesei modified (generic).