Title 40

PART 725

Part 725 - Reporting Requirements And Review Processes For Microorganisms

PART 725 - REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS Authority:15 U.S.C. 2604, 2607, 2613, and 2625. Source:62 FR 17932, Apr. 11, 1997, unless otherwise noted.

40:34.0.1.1.2.1SUBPART A
Subpart A - General Provisions and Applicability
40:34.0.1.1.2.1.1.1SECTION 725.1
   725.1 Scope and purpose.
40:34.0.1.1.2.1.1.2SECTION 725.3
   725.3 Definitions.
40:34.0.1.1.2.1.1.3SECTION 725.8
   725.8 Coverage of this part.
40:34.0.1.1.2.1.1.4SECTION 725.12
   725.12 Identification of microorganisms for Inventory and other listing purposes.
40:34.0.1.1.2.1.1.5SECTION 725.15
   725.15 Determining applicability when microorganism identity or use is confidential or uncertain.
40:34.0.1.1.2.1.1.6SECTION 725.17
   725.17 Consultation with EPA.
40:34.0.1.1.2.2SUBPART B
Subpart B - Administrative Procedures
40:34.0.1.1.2.2.1.1SECTION 725.20
   725.20 Scope and purpose.
40:34.0.1.1.2.2.1.2SECTION 725.25
   725.25 General administrative requirements.
40:34.0.1.1.2.2.1.3SECTION 725.27
   725.27 Submissions.
40:34.0.1.1.2.2.1.4SECTION 725.28
   725.28 Notice that submission is not required.
40:34.0.1.1.2.2.1.5SECTION 725.29
   725.29 EPA acknowledgement of receipt of submission.
40:34.0.1.1.2.2.1.6SECTION 725.32
   725.32 Errors in the submission.
40:34.0.1.1.2.2.1.7SECTION 725.33
   725.33 Incomplete submissions.
40:34.0.1.1.2.2.1.8SECTION 725.36
   725.36 New information.
40:34.0.1.1.2.2.1.9SECTION 725.40
   725.40 Notice in the Federal Register.
40:34.0.1.1.2.2.1.10SECTION 725.50
   725.50 EPA review.
40:34.0.1.1.2.2.1.11SECTION 725.54
   725.54 Suspension of the review period.
40:34.0.1.1.2.2.1.12SECTION 725.56
   725.56 Extension of the review period.
40:34.0.1.1.2.2.1.13SECTION 725.60
   725.60 Withdrawal of submission by the submitter.
40:34.0.1.1.2.2.1.14SECTION 725.65
   725.65 Recordkeeping.
40:34.0.1.1.2.2.1.15SECTION 725.67
   725.67 Applications to exempt new microorganisms from this part.
40:34.0.1.1.2.2.1.16SECTION 725.70
   725.70 Compliance.
40:34.0.1.1.2.2.1.17SECTION 725.75
   725.75 Inspections.
40:34.0.1.1.2.3SUBPART C
Subpart C - Confidentiality and Public Access to Information
40:34.0.1.1.2.3.1.1SECTION 725.80
   725.80 General provisions for confidentiality claims.
40:34.0.1.1.2.3.1.2SECTION 725.85
   725.85 Microorganism identity.
40:34.0.1.1.2.3.1.3SECTION 725.88
   725.88 Uses of a microorganism.
40:34.0.1.1.2.3.1.4SECTION 725.92
   725.92 Data from health and safety studies of microorganisms.
40:34.0.1.1.2.3.1.5SECTION 725.94
   725.94 Substantiation requirements.
40:34.0.1.1.2.3.1.6SECTION 725.95
   725.95 Public file.
40:34.0.1.1.2.4SUBPART D
Subpart D - Microbial Commercial Activities Notification Requirements
40:34.0.1.1.2.4.1.1SECTION 725.100
   725.100 Scope and purpose.
40:34.0.1.1.2.4.1.2SECTION 725.105
   725.105 Persons who must report.
40:34.0.1.1.2.4.1.3SECTION 725.110
   725.110 Persons not subject to this subpart.
40:34.0.1.1.2.4.1.4SECTION 725.150
   725.150 Procedural requirements for this subpart.
40:34.0.1.1.2.4.1.5SECTION 725.155
   725.155 Information to be included in the MCAN.
40:34.0.1.1.2.4.1.6SECTION 725.160
   725.160 Submission of health and environmental effects data.
40:34.0.1.1.2.4.1.7SECTION 725.170
   725.170 EPA review of the MCAN.
40:34.0.1.1.2.4.1.8SECTION 725.190
   725.190 Notice of commencement of manufacture or import.
40:34.0.1.1.2.5SUBPART E
Subpart E - Exemptions for Research and Development Activities
40:34.0.1.1.2.5.1.1SECTION 725.200
   725.200 Scope and purpose.
40:34.0.1.1.2.5.1.2SECTION 725.205
   725.205 Persons who may report under this subpart.
40:34.0.1.1.2.5.1.3SECTION 725.232
   725.232 Activities subject to the jurisdiction of other Federal programs or agencies.
40:34.0.1.1.2.5.1.4SECTION 725.234
   725.234 Activities conducted inside a structure.
40:34.0.1.1.2.5.1.5SECTION 725.235
   725.235 Conditions of exemption for activities conducted inside a structure.
40:34.0.1.1.2.5.1.6SECTION 725.238
   725.238 Activities conducted outside a structure.
40:34.0.1.1.2.5.1.7SECTION 725.239
   725.239 Use of specific microorganisms in activities conducted outside a structure.
40:34.0.1.1.2.5.1.8SECTION 725.250
   725.250 Procedural requirements for the TERA.
40:34.0.1.1.2.5.1.9SECTION 725.255
   725.255 Information to be included in the TERA.
40:34.0.1.1.2.5.1.10SECTION 725.260
   725.260 Submission of health and environmental effects data.
40:34.0.1.1.2.5.1.11SECTION 725.270
   725.270 EPA review of the TERA.
40:34.0.1.1.2.5.1.12SECTION 725.288
   725.288 Revocation or modification of TERA approval.
40:34.0.1.1.2.6SUBPART F
Subpart F - Exemptions for Test Marketing
40:34.0.1.1.2.6.1.1SECTION 725.300
   725.300 Scope and purpose.
40:34.0.1.1.2.6.1.2SECTION 725.305
   725.305 Persons who may apply under this subpart.
40:34.0.1.1.2.6.1.3SECTION 725.350
   725.350 Procedural requirements for this subpart.
40:34.0.1.1.2.6.1.4SECTION 725.355
   725.355 Information to be included in the TME application.
40:34.0.1.1.2.6.1.5SECTION 725.370
   725.370 EPA review of the TME application.
40:34.0.1.1.2.7SUBPART G
Subpart G - General Exemptions for New Microorganisms
40:34.0.1.1.2.7.1.1SECTION 725.400
   725.400 Scope and purpose.
40:34.0.1.1.2.7.1.2SECTION 725.420
   725.420 Recipient microorganisms.
40:34.0.1.1.2.7.1.3SECTION 725.421
   725.421 Introduced genetic material.
40:34.0.1.1.2.7.1.4SECTION 725.422
   725.422 Physical containment and control technologies.
40:34.0.1.1.2.7.1.5SECTION 725.424
   725.424 Requirements for the Tier I exemption.
40:34.0.1.1.2.7.1.6SECTION 725.426
   725.426 Applicability of the Tier I exemption.
40:34.0.1.1.2.7.1.7SECTION 725.428
   725.428 Requirements for the Tier II exemption.
40:34.0.1.1.2.7.1.8SECTION 725.450
   725.450 Procedural requirements for the Tier II exemption.
40:34.0.1.1.2.7.1.9SECTION 725.455
   725.455 Information to be included in the Tier II exemption request.
40:34.0.1.1.2.7.1.10SECTION 725.470
   725.470 EPA review of the Tier II exemption request.
40:34.0.1.1.2.8SUBPART H
Subparts H-K [Reserved]
40:34.0.1.1.2.9SUBPART L
Subpart L - Additional Procedures for Reporting on Significant New Uses of Microorganisms
40:34.0.1.1.2.9.1.1SECTION 725.900
   725.900 Scope and purpose.
40:34.0.1.1.2.9.1.2SECTION 725.910
   725.910 Persons excluded from reporting significant new uses.
40:34.0.1.1.2.9.1.3SECTION 725.912
   725.912 Exemptions.
40:34.0.1.1.2.9.1.4SECTION 725.920
   725.920 Exports and imports.
40:34.0.1.1.2.9.1.5SECTION 725.950
   725.950 Additional recordkeeping requirements.
40:34.0.1.1.2.9.1.6SECTION 725.975
   725.975 EPA approval of alternative control measures.
40:34.0.1.1.2.9.1.7SECTION 725.980
   725.980 Expedited procedures for issuing significant new use rules for microorganisms subject to section 5(e) orders.
40:34.0.1.1.2.9.1.8SECTION 725.984
   725.984 Modification or revocation of certain notification requirements.
40:34.0.1.1.2.10SUBPART M
Subpart M - Significant New Uses for Specific Microorganisms
40:34.0.1.1.2.10.1.1SECTION 725.1000
   725.1000 Scope.
40:34.0.1.1.2.10.1.2SECTION 725.1075
   725.1075 Burkholderia cepacia complex.