cfr_sections
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75 rows where part_number = 725 and title_number = 40 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 40:40:34.0.1.1.2.1.1.1 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | A | Subpart A—General Provisions and Applicability | § 725.1 Scope and purpose. | EPA | (a) This part establishes all reporting requirements under section 5 of TSCA for manufacturers, importers, and processors of microorganisms subject to TSCA jurisdiction for commercial purposes, including research and development for commercial purposes. New microorganisms for which manufacturers and importers are required to report under section 5(a)(1)(A) of TSCA are those that are intergeneric. In addition, under section 5(a)(1)(B) of TSCA, manufacturers, importers, and processors may be required to report for any microorganism that EPA determines by rule is being manufactured, imported, or processed for a significant new use. (b) Any manufacturer, importer, or processor required to report under section 5 of TSCA (see § 725.100 for new microorganisms and § 725.900 for significant new uses) must file a Microbial Commercial Activity Notice (MCAN) with EPA, unless the activity is eligible for a specific exemption as described in this part. The general procedures for filing MCANs are described in subpart D of this part. The exemptions from the requirement to file a MCAN are for certain kinds of contained activities (see §§ 725.424 and 725.428), test marketing activities (see § 725.300), and research and development activities described in paragraph (c) of this section. (c) Any manufacturer, importer, or processor required to file a MCAN for research and development (R&D) activities may instead file a TSCA Experimental Release Application (TERA) for a specific test (see § 725.250). A TERA is not required for certain R&D activities; however a TERA exemption does not extend beyond the research and development stage, to general commercial use of the microorganism, for which compliance with MCAN requirements is required. The TERA exemptions are for R&D activities subject to other Federal agencies or programs (see § 725.232), certain kinds of contained R&D activities (see § 725.234), and R&D activities using certain listed microorganisms (see § 725.238). (d) New microorganisms will be added to the Inventory establishe… | ||||
| 40:40:34.0.1.1.2.1.1.2 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | A | Subpart A—General Provisions and Applicability | § 725.3 Definitions. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 85 FR 13772, Mar. 10, 2020] | Definitions in section 3 of the Act (15 U.S.C. 2602), as well as definitions contained in §§ 704.3, 720.3, and 721.3 of this chapter, apply to this part unless otherwise specified in this section. In addition, the following definitions apply to this part: Consolidated microbial commercial activity notice or consolidated MCAN means any MCAN submitted to EPA that covers more than one microorganism (each being assigned a separate MCAN number by EPA) as a result of a prenotice agreement with EPA. Containment and/or inactivation controls means any combination of engineering, mechanical, procedural, or biological controls designed and operated to restrict environmental release of viable microorganisms from a structure. Director means the Director of the EPA Office of Pollution Prevention and Toxics. Exemption request means any application submitted to EPA under subparts E, F, or G of this part. General commercial use means use for commercial purposes other than research and development. Genome means the sum total of chromosomal and extrachromosomal genetic material of an isolate and any descendants derived under pure culture conditions from that isolate. Health and safety study of a microorganism or health and safety study means any study of any effect of a microorganism or microbial mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a microorganism or microbial mixture, toxicological, clinical, and ecological, or other studies of a microorganism or microbial mixture, and any test performed under the Act. Microorganism identity is always part of a health and safety study of a microorganism. (1) It is intended that the term “health and safety study of a microorganism” be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a microorganism or microbial mixture on health or the environment is also included. Any… | |||
| 40:40:34.0.1.1.2.1.1.3 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | A | Subpart A—General Provisions and Applicability | § 725.8 Coverage of this part. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 89 FR 102799, Dec. 18, 2024] | (a) Microorganisms subject to this part. Only microorganisms which are manufactured, imported, or processed for commercial purposes, as defined in § 725.3, are subject to the requirements of this part. (b) Microorganisms automatically included on the Inventory. Microorganisms that are not intergeneric are automatically included on the Inventory. (c) Microorganisms not subject to this part. The following microorganisms are not subject to this part, either because they are not subject to jurisdiction under the Act or are not subject to reporting under section 5 of the Act. (1) Any microorganism which would be excluded from the definition of “chemical substance” in section 3 of the Act and § 720.3 of this chapter. (2) Any microbial mixture as defined in § 725.3. This exclusion applies only to a microbial mixture as a whole and not to any microorganisms and other chemical substances which are part of the microbial mixture. (3) Any microorganism that is manufactured and processed solely for export if the following conditions are met: (i) The microorganism is labeled in accordance with section 12(a)(1)(B) of the Act, when the microorganism is distributed in commerce. (ii) The manufacturer and processor can document at the commencement of manufacturing or processing that the person to whom the microorganism will be distributed intends to export it or process it solely for export as defined in § 721.3 of this chapter. | |||
| 40:40:34.0.1.1.2.1.1.4 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | A | Subpart A—General Provisions and Applicability | § 725.12 Identification of microorganisms for Inventory and other listing purposes. | EPA | To identify and list microorganisms on the Inventory, both taxonomic designations and supplemental information will be used. The supplemental information required in paragraph (b) of this section will be used to specifically describe an individual microorganism on the Inventory. Submitters must provide the supplemental information required by paragraph (b) of this section to the extent necessary to enable a microorganism to be accurately and unambiguously identified on the Inventory. (a) Taxonomic designation. The taxonomic designation of a microorganism must be provided for the donor organism and the recipient microorganism to the level of strain, as appropriate. These designations must be substantiated by a letter from a culture collection, literature references, or the results of tests conducted for the purpose of taxonomic classification. Upon EPA's request to the submitter, data supporting the taxonomic designation must be provided to EPA. The genetic history of the recipient microorganism should be documented back to the isolate from which it was derived. (b) Supplemental information. The supplemental information described in paragraphs (b)(1) and (b)(2) of this section is required to the extent that it enables a microorganism to be accurately and unambiguously identified. (1) Phenotypic information. Phenotypic information means pertinent traits that result from the interaction of a microorganism's genotype and the environment in which it is intended to be used and may include intentionally added biochemical and physiological traits. (2) Genotypic information. Genotypic information means the pertinent and distinguishing genotypic characteristics of a microorganism, such as the identity of the introduced genetic material and the methods used to construct the reported microorganism. This also may include information on the vector construct, the cellular location, and the number of copies of the introduced genetic material. | ||||
| 40:40:34.0.1.1.2.1.1.5 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | A | Subpart A—General Provisions and Applicability | § 725.15 Determining applicability when microorganism identity or use is confidential or uncertain. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 80 FR 42747, July 20, 2015] | (a) Consulting EPA. Persons intending to conduct activities involving microorganisms may determine their obligations under this part by consulting the Inventory or the microorganisms and uses specified in § 725.239 or in subpart M of this part. This section establishes procedures for EPA to assist persons in determining whether the microorganism or the use is listed on the Inventory, in § 725.239 or in subpart M of this part. (1) Confidential identity or use. In some cases it may not be possible to directly determine if a specific microorganism is listed, because portions of that entry may contain generic information to protect confidential business information (CBI). If any portion of the microorganism's identity or use has been claimed as CBI, that portion does not appear on the public version of the Inventory, in § 725.239 or in subpart M of this part. Instead, it is contained in a confidential version held in EPA's Confidential Business Information Center (CBIC). The public versions contain generic information which masks the confidential business information. A person who intends to conduct an activity involving a microorganism or use whose entry is described with generic information will need to inquire of EPA whether the unreported microorganism or use is on the confidential version. (2) Uncertain microorganism identity. The current state of scientific knowledge leads to some imprecision in describing a microorganism. As the state of knowledge increases, EPA will be developing policies to determine whether one microorganism is equivalent to another. Persons intending to conduct activities involving microorganisms may inquire of EPA whether the microorganisms they intend to manufacture (including import) or process are equivalent to specific microorganisms described on the Inventory, in § 725.239, or in subpart M of this part. (b) Requirement of bona fide intent. (1) EPA will answer the inquiries described in paragraph (a) of this section only if the Agency determines that the person has a bona … | |||
| 40:40:34.0.1.1.2.1.1.6 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | A | Subpart A—General Provisions and Applicability | § 725.17 Consultation with EPA. | EPA | Persons may consult with EPA, either in writing or by telephone, about their obligations under this part. Written consultation is preferred. Written inquiries should be sent to the following address: Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: Biotechnology Notice Consultation. Persons wishing to consult with EPA by telephone should call (202) 554-1404; hearing impaired TDD (202) 554-0551 or e-mail: TSCA-Hotline@epamail.epa.gov. | ||||
| 40:40:34.0.1.1.2.10.1.1 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | M | Subpart M—Significant New Uses for Specific Microorganisms | § 725.1000 Scope. | EPA | This subpart identifies uses of microorganisms which EPA has determined to be significant new uses under the authority of section 5(a)(2) of the Toxic Substances Control Act. | ||||
| 40:40:34.0.1.1.2.10.1.2 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | M | Subpart M—Significant New Uses for Specific Microorganisms | § 725.1075 Burkholderia cepacia complex. | EPA | [68 FR 35320, June 13, 2003] | (a) Microorganism and significant new uses subject to reporting. (1) The microorganisms identified as the Burkholderia cepacia complex defined as containing the following nine species, Burkholderia cepacia, Burkholderia multivorans, Burkholderia stabilis, Burkholderia vietnamiensis, Burkholderia ambifaria, Burkholderia pyrrocinia, Burkholderia cepacia genomovar VIII ( Burkholderia anthina ), and Burkholderia cepacia genomovars III and VI are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new use is any use other than research and development in the degradation of chemicals via injection into subsurface groundwater. (b) [Reserved] | |||
| 40:40:34.0.1.1.2.10.1.3 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | M | Subpart M—Significant New Uses for Specific Microorganisms | § 725.1079 Arsenic detecting strain of E. coli with extra-chromosomal elements, including an intergeneric screening marker (generic). | EPA | [86 FR 24336, May 6, 2021] | (a) Microorganism and significant new uses subject to reporting. (1) The genetically-modified microorganism identified generically as arsenic detecting strain of E. coli with extra-chromosomal elements, including an intergeneric screening marker (MCAN J-18-41) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) It is a significant new use to manufacture (excluding import) the microorganism in the United States for any use. (ii) It is a significant new use to use the microorganism other than to detect arsenic in small water samples. (b) Specific requirements. The provisions of subpart L of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 725.950(b)(2) through (4) are applicable to manufacturers and processors of this microorganism. (2) Modification or revocation of certain notification requirements. The provisions of § 725.984 apply to this section. | |||
| 40:40:34.0.1.1.2.10.1.4 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | M | Subpart M—Significant New Uses for Specific Microorganisms | § 725.1080 Trichoderma reesei (generic). | EPA | [86 FR 22875, Apr. 30, 2021] | (a) Microorganism and significant new uses subject to reporting. (1) The genetically modified microorganism identified as Trichoderma reesei strain 3CH-3 (MCAN J-19-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2)(i) The significant new use is any manufacturing, processing, or use of the microorganism other than in a fermentation system that meets all of the following conditions: (A) Enzyme production occurs by submerged fermentation ( i.e., for enzyme production, growth of the microorganism occurs beneath the surface of the liquid growth medium); and (B) Any further fermentation, such as saccharification ( i.e., addition of Trichoderma reesei fermentation broth to solid plant material or insoluble substrate after the standard industrial fermentation is completed), is initiated only after the inactivation of the microorganism as delineated in § 725.422(d). (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) though (c) and (i) of this chapter, are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 of this chapter apply to this section. | |||
| 40:40:34.0.1.1.2.10.1.5 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | M | Subpart M—Significant New Uses for Specific Microorganisms | § 725.1081 Trichoderma reesei modified (generic). | EPA | [87 FR 73955, Dec. 2, 2022] | (a) Microorganism and significant new uses subject to reporting. (1) The genetically modified microorganism generically identified as Trichoderma reesei modified (MCAN J-16-26) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2)(i) It is a significant new use to manufacture, process, or use the microorganism other than in a fermentation system that meets all of the following conditions: (A) Enzyme production occurs by submerged fermentation ( i.e., for enzyme production, growth of the microorganism occurs beneath the surface of the liquid growth medium); and (B) Any fermentation of solid plant material or insoluble substrate to which Trichoderma reesei fermentation broth is added after the standard industrial fermentation is completed is initiated only after the inactivation of the microorganism as delineated in § 725.422(d). (ii) [Reserved] (b) Specific requirements. The provisions of subpart L of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 725.950(b)(2) through (4) are applicable to manufacturers and processors of this microorganism. (2) Modification or revocation of certain notification requirements. The provisions of § 725.984 apply to this section. | |||
| 40:40:34.0.1.1.2.10.1.6 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | M | Subpart M—Significant New Uses for Specific Microorganisms | § 725.1082 Microorganism expressing enzymes (generic). | EPA | [90 FR 35638, July 29, 2025] | (a) Microorganism and significant new uses subject to reporting. (1) The genetically-modified microorganism identified generically as microorganism expressing enzymes (MCAN J-23-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) It is a significant new use to manufacture, process, or use the microorganism other than in a fermentation system that meets all of the following conditions: (A) Enzyme production occurs by submerged fermentation ( i.e., for enzyme production, growth of the microorganism occurs beneath the surface of the liquid growth medium); and (B) Any fermentation of solid plant material or insoluble substrate to which the microorganism fermentation broth is added after the standard industrial fermentation is completed is initiated only after the inactivation of the microorganism as delineated in § 725.422(d). (ii) [Reserved] (b) Specific requirements. The provisions of subpart L of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 725.950(b)(2) through (4) are applicable to manufacturers and processors of this microorganism. (2) Modification or revocation of certain notification requirements. The provisions of § 725.984 apply to this section. | |||
| 40:40:34.0.1.1.2.2.1.1 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.20 Scope and purpose. | EPA | This subpart describes general administrative procedures applicable to all persons who submit MCANs and exemption requests to EPA under section 5 of the Act for microorganisms. | ||||
| 40:40:34.0.1.1.2.2.1.10 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.50 EPA review. | EPA | (a) MCANs. The review period specified in section 5(a) of the Act for MCANs runs for 90 days from the date the Document Control Officer receives a complete submission, or the date EPA determines the submission is complete under § 725.33, unless the Agency extends the review period under section 5(c) of the Act and § 725.56. (b) Exemption requests. The review period starts on the date the Document Control Officer receives a complete exemption request, or the date EPA determines the request is complete under § 725.33, unless the Agency extends the review period under § 725.56. The review periods for exemption requests run as follows: (1) TERAs. The review period for TERAs is 60 days. (2) TMEs. The review period for TMEs is 45 days. (3) Tier II exemption requests. The review period for Tier II exemption requests is 45 days. | ||||
| 40:40:34.0.1.1.2.2.1.11 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.54 Suspension of the review period. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013; 89 FR 102799, Dec. 18, 2024] | (a) A submitter may voluntarily suspend the running of the review period if the Director, or a designee, agrees. If the Director does not agree, the review period will continue to run, and EPA will notify the submitter. A submitter may request a suspension at any time during the review period. The suspension must be for a specified period of time. (b)(1) Request for suspension. A request for suspension may only be submitted in a manner set forth in this paragraph. The request for suspension also may be made orally, including by telephone, or in writing, including by e-mail, to the submitter's EPA contact for that notice, subject to paragraph (c) of this section. (2) Submission of suspension notices. EPA will accept requests for suspension only if submitted in accordance with this paragraph. Requests for suspension, must be generated, completed, and submitted to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software. (c) An oral or written request for suspension may be granted by EPA for a maximum of 30 days only. Requests for longer suspension must only be submitted in the manner set forth in paragraph (b)(2) of this section. (d) If the submitter has not made a previous oral or written request, the running of the applicable review period is suspended as of the date of receipt of the CDX submission by EPA. | |||
| 40:40:34.0.1.1.2.2.1.12 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.56 Extension of the review period. | EPA | (a) At any time during the review period, EPA may unilaterally determine that good cause exists to extend the review period specified for MCANs, or the exemption requests. (b) If EPA makes such a determination, EPA: (1) Will notify the submitter that EPA is extending the review period for a specified length of time and state the reasons for the extension. (2) For MCANs, EPA may issue a notice for publication in the Federal Register which states that EPA is extending the review period and gives the reasons for the extension. (c) The total period of the extension may be for a period of up to the same length of time as specified for each type of submission in § 725.50. If the initial extension is for less than the total time allowed, EPA may make additional extensions. However, the sum of the extensions may not exceed the total allowed. (d) The following are examples of situations in which EPA may find that good cause exists for extending the review period: (1) EPA has reviewed the submission and is seeking additional information. (2) EPA has received significant additional information during the review period. (3) The submitter has failed to correct a submission after receiving EPA's request under § 725.32. (4) EPA has reviewed the submission and determined that there is a significant possibility that the microorganism will be regulated under section 5(e) or section 5(f) of the Act, but EPA is unable to initiate regulatory action within the initial review period. | ||||
| 40:40:34.0.1.1.2.2.1.13 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.60 Withdrawal of submission by the submitter. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013; 89 FR 102799, Dec. 18, 2024] | (a)(1) Withdrawal of notice by the submitter. A submitter may withdraw a notice during the applicable review period by submitting a statement of withdrawal in a manner set forth in this paragraph. The withdrawal is effective upon receipt of the CDX submission by EPA. (2) Submission of withdrawal notices. EPA will accept statements of withdrawal only if submitted in accordance with this paragraph. Statements of withdrawal must be generated, completed, and submitted to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software. (b) If a manufacturer, importer, or processor who withdrew a submission later resubmits a submission for the same microorganism, a new review period begins. | |||
| 40:40:34.0.1.1.2.2.1.14 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.65 Recordkeeping. | EPA | (a) General provisions. (1) Any person who submits a notice under this part must retain documentation of information in the submission, including: (i) Any data in the submitter's possession or control; and (ii) Records of production volume for the first 3 years of manufacture, import, or processing. (2) Any person who submits a notice under this part must retain documentation of the date of commencement of testing, manufacture, import, or processing. (3) Any person who is exempt from some or all of the reporting requirements of this part must retain documentation that supports the exemption. (4) All information required by this section must be retained for 3 years from the date of commencement of each activity for which records are required under this part. (b) Specific requirements. In addition to the requirements of paragraph (a) of this section, specific recordkeeping requirements included in certain subparts must also be followed. (1) Additional recordkeeping requirements for activities conducted inside a structure are set forth in § 725.235(h). (2) Additional recordkeeping requirements for TERAs are set forth in § 725.250(f). (3) Additional recordkeeping requirements for TMEs are set forth in § 725.350(c). (4) Additional recordkeeping requirements for Tier I exemptions under subpart G of this part are set forth in § 725.424(a)(5). (5) Additional recordkeeping requirements for Tier II exemptions under subpart G of this part are set forth in § 725.450(d). (6) Additional recordkeeping requirements for significant new uses of microorganisms reported under subpart L of this part are set forth in § 725.850. Recordkeeping requirements may also be included when a microorganism and significant new use are added to subpart M of this part. | ||||
| 40:40:34.0.1.1.2.2.1.15 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.67 Applications to exempt new microorganisms from this part. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 77 FR 46292, Aug. 3, 2012] | (a) Submission. (1) Any manufacturer or importer of a new microorganism may request, under TSCA section 5(h)(4), an exemption, in whole or in part, from this part by sending a Letter of Application in the manner set forth in § 725.25(c). (2) General provisions. The Letter of Application should provide information to show that any activities affected by the requested exemption will not present an unreasonable risk of injury to health or the environment. This information should include data described in the following paragraphs. (i) The effects of the new microorganism on health and the environment. (ii) The magnitude of exposure of human beings and the environment to the new microorganism. (iii) The benefits of the new microorganism for various uses and the availability of substitutes for such uses. (iv) The reasonably ascertainable economic consequences of granting or denying the exemption, including effects on the national economy, small business, and technological innovation. (3) Specific requirements. In addition to the requirements of paragraph (a)(2) of this section, the specific information requirements of the relevant subpart under which the exemption is sought should be met. (i) Exemption from MCAN reporting under subpart D. Information requirements are set forth in §§ 725.155 and 725.160. (ii) Exemption from TERA reporting under subpart E. Information requirements are set forth in §§ 725.255 and 725.260. (iii) Listing a recipient microorganism as eligible for exemption under subpart G. Information regarding the following criteria should be addressed in an application to list a recipient microorganism under § 725.420: (A) Identification and classification of the microorganism using available genotypic and phenotypic information; (B) Information to evaluate the relationship of the microorganism to any other closely related microorganisms which have a potential for adverse effects on health or the environment; (C) A history of safe commercial use for the microorganism; (D) Commercia… | |||
| 40:40:34.0.1.1.2.2.1.16 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.70 Compliance. | EPA | (a) Failure to comply with any provision of this part is a violation of section 15 of the Act (15 U.S.C. 2614). (b) A person who manufactures or imports a microorganism before a MCAN is submitted and the MCAN review period expires is in violation of section 15 of the Act even if that person was not required to submit the MCAN under § 725.105. (c) Using a microorganism which a person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of section 5 of the Act or this part is a violation of section 15 of the Act (15 U.S.C. 2614). (d) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by the Act, is a violation of section 15 of the Act (15 U.S.C. 2614). (e) Failure or refusal to permit entry or inspection as required by section 11 of the Act is a violation of section 15 of the Act (15 U.S.C. 2614). (f) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who submit materially misleading or false information in connection with the requirements of any provision of this part may be subject to penalties calculated as if they never filed their submissions. (g) EPA may seek to enjoin the manufacture or processing of a microorganism in violation of this part or act to seize any microorganism manufactured or processed in violation of this part or take other actions under the authority of section 7 of the Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616). | ||||
| 40:40:34.0.1.1.2.2.1.17 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.75 Inspections. | EPA | EPA will conduct inspections under section 11 of the Act to assure compliance with section 5 of the Act and this part, to verify that information required by EPA under this part is true and correct, and to audit data submitted to EPA under this part. | ||||
| 40:40:34.0.1.1.2.2.1.2 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.25 General administrative requirements. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013; 83 FR 52723, Oct. 17, 2018] | (a) General. (1) Each person who is subject to the notification provisions of this part must complete, sign, and submit a MCAN or exemption request containing the information as required for the appropriate submission under this part. Except as otherwise provided, each submission must include all referenced attachments. All information in the submission (unless certain attachments appear in the open scientific literature) must be in English. All information submitted must be true and correct. (2) In addition to specific information required, the submitter should submit all information known to or reasonably ascertainable by the submitter that would permit EPA to make a reasoned evaluation of the human health and environmental effects of the microorganism and any microbial mixture or article that may contain the microorganism. (b) Certification. Persons submitting MCANs and exemption requests to EPA under this part, and material related to their reporting obligations under this part, must attach the following statement to any information submitted to EPA. This statement must be signed and dated by an authorized official of the submitter: I certify that to the best of my knowledge and belief: The company named in this submission intends to manufacture, import, or process for a commercial purpose, other than in small quantities solely for research and development, the microorganism identified in this submission. All information provided in this submission is complete and truthful as of the date of submission. I am including with this submission all test data in my possession or control and a description of all other data known to or reasonably ascertainable by me as required by 40 CFR 725.160 or 725.260. I certify that to the best of my knowledge and belief: The company named in this submission intends to manufacture, import, or process for a commercial purpose, other than in small quantities solely for research and development, the microorganism identified in this submission. All information provided in thi… | |||
| 40:40:34.0.1.1.2.2.1.3 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.27 Submissions. | EPA | Each person who is required to submit information under this part must submit the information in the form and manner set forth in the appropriate subpart. (a) Requirements specific to MCANs are described in §§ 725.150 through 725.160. (b) Requirements specific to TERAs are described in §§ 725.250 through 725.260. (c) Requirements specific to test marketing exemptions (TMEs) are described in §§ 725.350 and 725.355. (d) Requirements specific to Tier I and Tier II exemptions for certain general commercial uses are described in §§ 725.424 through 725.470. (e) Additional requirements specific to significant new uses for microorganisms are described at § 725.950. | ||||
| 40:40:34.0.1.1.2.2.1.4 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.28 Notice that submission is not required. | EPA | When EPA receives a MCAN or exemption request, EPA will review it to determine whether the microorganism is subject to the requirements of this part. If EPA determines that the microorganism is not subject to these requirements, EPA will notify the submitter that section 5 of the Act does not prevent the manufacture, import, or processing of the microorganism and that the submission is not needed. | ||||
| 40:40:34.0.1.1.2.2.1.5 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.29 EPA acknowledgement of receipt of submission. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010] | (a) EPA will acknowledge receipt of each submission by sending a letter via CDX or U.S. mail to the submitter that identifies the number assigned to each MCAN or exemption request and the date on which the review period begins. The review period will begin on the date the MCAN or exemption request is received by the Office of Pollution Prevention and Toxics Document Control Officer. (b) The acknowledgement does not constitute a finding by EPA that the submission is in compliance with this part. | |||
| 40:40:34.0.1.1.2.2.1.6 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.32 Errors in the submission. | EPA | (a) Within 30 days of receipt of the submission, EPA may request that the submitter remedy errors in the submission. The following are examples of such errors: (1) Failure to date the submission. (2) Typographical errors that cause data to be misleading or answers to any questions to be unclear. (3) Contradictory information. (4) Ambiguous statements or information. (b) In the request to correct the submission, EPA will explain the action which the submitter must take to correct the submission. (c) If the submitter fails to correct the submission within 15 days of receipt of the request, EPA may extend the review period. | ||||
| 40:40:34.0.1.1.2.2.1.7 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.33 Incomplete submissions. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010; 83 FR 52723, Oct. 17, 2018] | (a) A submission under this part is not complete, and the review period does not begin, if: (1) The wrong person files the submission. (2) The submitter does not attach and sign the certification statement as required by § 725.25(b). (3) Some or all of the information in the submission or any attachments are not in English, except for published scientific literature. (4) The submitter does not provide information that is required by sections 5(d)(1)(B) and (C) of the Act and § 725.160 or 725.260, as appropriate. (5) The submitter does not provide information required by § 725.25, § 725.155, § 725.255, § 725.355, or § 725.455, as appropriate, or indicate that it is not known to or reasonably ascertainable by the submitter. (6) The submitter has asserted confidentiality claims and has failed to: (i) Submit a second copy of the submission with all confidential information deleted for the public file, as required by § 725.80(b)(2). (ii) Comply with the substantiation requirements as described in § 725.94. (7) The submitter does not include any information required by section 5(b)(1) of the Act and pursuant to a rule promulgated under section 4 of the Act, as required by § 725.25(f). (8) The submitter does not submit data which the submitter believes show that the microorganism will not present an unreasonable risk of injury to health or the environment, if EPA has listed the microorganism under section 5(b)(4) of the Act, as required in § 725.25(g). (9) The submitter does not remit the fees required by § 700.45(c) of this chapter. (10) The submitter does not include an identifying number and a payment identity number. (11) The submitter does not submit the notice in the manner set forth in § 725.25(c). (b)(1) If EPA receives an incomplete submission under this part, the Director, or a designee, will notify the submitter within 30 days of receipt that the submission is incomplete and that the review period will not begin until EPA receives a complete submission. (2) If EPA obtains additional information… | |||
| 40:40:34.0.1.1.2.2.1.8 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.36 New information. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010] | (a) During the review period, if a submitter possesses, controls, or knows of new information that materially adds to, changes, or otherwise makes significantly more complete the information included in the MCAN or exemption request, the submitter must send that information within 10 days of receiving the new information, but no later than 5 days before the end of the review period. The new information must be sent in the same manner the original notice or exemption was sent, as described in § 725.25(c)(1), (c)(2), and (c)(3). (b) The new submission must clearly identify the submitter, the MCAN or exemption request to which the new information is related, and the number assigned to that submission by EPA, if known to the submitter. (c) If the new information becomes available during the last 5 days of the review period, the submitter must immediately inform the EPA contact for that submission by telephone of the new information. | |||
| 40:40:34.0.1.1.2.2.1.9 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | B | Subpart B—Administrative Procedures | § 725.40 Notice in the Federal Register. | EPA | (a) Filing of Federal Register notice. After EPA receives a MCAN or an exemption request under this part, EPA will issue a notice in the Federal Register including the information specified in paragraph (b) of this section. (b) Contents of notice. (1) In the public interest, the specific microorganism identity listed in the submission will be published in the Federal Register unless the submitter has claimed the microorganism identity confidential. If the submitter claims confidentiality, a generic name will be published in accordance with § 725.85. (2) The categories of use of the microorganism will be published as reported in the submission unless this information is claimed confidential. If confidentiality is claimed, the generic information which is submitted under § 725.88 will be published. (3) A list of information submitted in accordance with § 725.160(a), § 725.255, § 725.260, § 725.355, or § 725.455, as appropriate, will be published. (4) The submitter's identity will be published, unless the submitter has claimed it confidential. (c) Publication of exemption decisions. Following the expiration of the appropriate review period for the exemption request, EPA will issue a notice in the Federal Register indicating whether the request has been approved or denied and the reasons for the decision. | ||||
| 40:40:34.0.1.1.2.3.1.1 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | C | Subpart C—Confidentiality and Public Access to Information | § 725.80 General provisions for confidentiality claims. | EPA | [88 FR 37173, June 7, 2023] | Claims of confidentiality must be made in accordance with the procedures described in 40 CFR part 703, except as modified in this paragraph. In general, references to “chemical” or “chemical identity” in part 703 are equivalent to “microorganism” or “microorganism identity” for the purposes of this part. (a) In place of § 703.5(b)(3)(v) of this subchapter, the following question must be answered: Has EPA, another Federal agency, or court made any confidentiality determination regarding information associated with this microorganism? If yes, please provide the circumstances associated with the prior determination, whether the information was found to be entitled to confidential treatment, the entity that made the decision, and the date of the determination. (b) In place of § 703.5(b)(4) of this subchapter, the following questions apply: (1) Has the identity of the microorganism been kept confidential to the extent that competitors do not know it is being manufactured or imported into US commerce? If not, explain why the microorganism identity should still be afforded confidential status (e.g., the microorganism is publicly known only as being distributed in commerce for research and development purposes, but no other information about the current commercial distribution of the microorganism in the United States is publicly available). (2) Does the microorganism leave the site of production or testing in a form which is accessible to the public or to competitors? If yes, please explain what measures have been taken to guard against the discovery of its identity. Further, what is the cost to a competitor, in time and money, to develop appropriate use conditions? What factors facilitate or impede product analysis? | |||
| 40:40:34.0.1.1.2.3.1.2 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | C | Subpart C—Confidentiality and Public Access to Information | § 725.88 Uses of a microorganism. | EPA | (a) Assertion of claim. A person who submits information to EPA under this part on the categories or proposed categories of use of a microorganism may assert a claim of confidentiality for this information. (b) Requirements for claim. A submitter that asserts such a claim must: (1) Report the categories or proposed categories of use of the microorganism. (2) Provide, in nonconfidential form, a description of the uses that is only as generic as necessary to protect the confidential business information. The generic use description will be included in the Federal Register notice described in § 725.40. (c) Generic use description. The person must submit the information required by paragraph (b) of this section by describing the uses as precisely as possible, without revealing the information which is claimed confidential, to disclose as much as possible how the use may result in human exposure to the microorganism or its release to the environment. | ||||
| 40:40:34.0.1.1.2.3.1.3 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | C | Subpart C—Confidentiality and Public Access to Information | § 725.95 Public file. | EPA | [88 FR 37174, June 7, 2023] | All information submitted, including any health and safety study of a microorganism and other supporting documentation, will become part of the public file for that submission, unless such materials are claimed as confidential in accordance with this section. In addition, EPA may add materials to the public file, subject to subpart C of this part. Publicly available materials are available at the docket addresses in § 700.17(b)(1) and (2) of this subchapter and on EPA's website. | |||
| 40:40:34.0.1.1.2.4.1.1 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | D | Subpart D—Microbial Commercial Activities Notification Requirements | § 725.100 Scope and purpose. | EPA | (a) This subpart establishes procedures for submission of a notice to EPA under section 5(a) of the Act for persons who manufacture, import, or process microorganisms for commercial purposes. This notice is called a Microbial Commercial Activity Notice (MCAN). It is expected that MCANs will in general only be submitted for microorganisms intended for general commercial use. Persons who manufacture, import, or process a microorganism in small quantities solely for research and development as defined in § 725.3 are not required to submit a notice to EPA. Persons who manufacture, import, or process a microorganism for research and development activities that do not fit the definition of small quantities solely for research and development may nonetheless qualify for more limited reporting requirements in subpart E, including the TERA which can be used for review of research and development involving environmental release. (b) Persons subject to MCAN submission are described in § 725.105. (c) Exclusions and exemptions specific to MCAN submissions are described in § 725.110. (d) Submission requirements applicable specifically to MCANs are described at § 725.150. (e) Data requirements for MCANs are set forth in §§ 725.155 and 725.160. (f) EPA review procedures specific to MCANs are set forth in § 725.170. (g) Subparts A through C of this part apply to any MCAN submitted under this subpart. | ||||
| 40:40:34.0.1.1.2.4.1.2 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | D | Subpart D—Microbial Commercial Activities Notification Requirements | § 725.105 Persons who must report. | EPA | (a) Manufacturers of new microorganisms. (1) MCAN submission is required for any person who intends to manufacture for commercial purposes in the United States a new microorganism. Exclusions are described in § 725.110. (2) If a person contracts with a manufacturer to produce or process a new microorganism and the manufacturer produces or processes the microorganism exclusively for that person, and that person specifies the identity of the microorganism, and controls the total amount produced and the basic technology for the plant process, then that person must submit the MCAN. If it is unclear who must report, EPA should be contacted to determine who must submit the MCAN. (3) Only manufacturers that are incorporated, licensed, or doing business in the United States may submit a MCAN. (b) Importers of new microorganisms. (1) MCAN submission is required for a person who intends to import into the United States for commercial purposes a new microorganism. Exclusions are described in § 725.110. (2) When several persons are involved in an import transaction, the MCAN must be submitted by the principal importer. If no one person fits the principal importer definition in a particular transaction, the importer should contact EPA to determine who must submit the MCAN for that transaction. (3) Except as otherwise provided in paragraph (b)(4) of this section, the provisions of this subpart D apply to each person who submits a MCAN for a new microorganism which such person intends to import for a commercial purpose. In addition, each importer must comply with paragraph (b)(4) of this section. (4) EPA will hold the principal importer, or the importer that EPA determines must submit the MCAN when there is no principal importer under paragraph (b)(2) of this section, liable for complying with this part, for completing the MCAN, and for the completeness and truthfulness of all information which it submits. (c) Manufacturers, importers, or processors of microorganisms for a significant new use. MCAN submission is re… | ||||
| 40:40:34.0.1.1.2.4.1.3 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | D | Subpart D—Microbial Commercial Activities Notification Requirements | § 725.110 Persons not subject to this subpart. | EPA | Persons are not subject to the requirements of this subpart for the following activities: (a) Manufacturing, importing, or processing solely for research and development microorganisms that meet the requirements for an exemption under subpart E of this part. (b) Manufacturing, importing, or processing microorganisms for test marketing activities which have been granted an exemption under subpart F of this part. (c) Manufacturing or importing new microorganisms under the conditions of a Tier I or Tier II exemption under subpart G of this part. | ||||
| 40:40:34.0.1.1.2.4.1.4 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | D | Subpart D—Microbial Commercial Activities Notification Requirements | § 725.150 Procedural requirements for this subpart. | EPA | General requirements for all MCANs under this part are contained in subparts A through C of this part. In addition, the following requirements apply to MCANs submitted under this subpart: (a) When to submit a MCAN. A MCAN must be submitted at least 90 calendar days prior to manufacturing or importing a new microorganism and at least 90 calendar days prior to manufacturing, importing, or processing a microorganism for a significant new use. (b) Section 5(b) of the Act. The submitter must comply with any applicable requirement of section 5(b) of the Act for the submission of test data. (c) Contents of a MCAN. Each person who submits a MCAN under this subpart must provide the information and test data described in §§ 725.155 and 725.160. (d) Recordkeeping. Each person who submits a MCAN under this subpart must comply with the recordkeeping requirements of § 725.65. | ||||
| 40:40:34.0.1.1.2.4.1.5 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | D | Subpart D—Microbial Commercial Activities Notification Requirements | § 725.155 Information to be included in the MCAN. | EPA | (a) Each person who is required by this part to submit a MCAN must include the information specified in paragraphs (c) through (h) of this section, to the extent it is known to or reasonably ascertainable by that person. However, no person is required to include information which relates solely to exposure of humans or ecological populations outside of the United States. (b) Each person should also submit, in writing, all other information known to or reasonably ascertainable by that person that would permit EPA to make a reasoned evaluation of the health and environmental effects of the microorganism, or any microbial mixture or article, including information on its effects on humans, animals, plants, and other microorganisms, and in the environment. The information to be submitted under this subpart includes the information listed in paragraphs (c) through (h) of this section relating to the manufacture, processing, distribution in commerce, use, and disposal of the new microorganism. (c) Submitter identification. (1) The name and headquarters address of the submitter. (2) The name, address, and office telephone number (including area code) of the principal technical contact representing the submitter. (d) Microorganism identity information. Persons must submit sufficient information to allow the microorganism to be accurately and unambiguously identified for listing purposes as required by § 725.12. (1) Description of the recipient microorganism and the new microorganism. (i) Data substantiating the taxonomy of the recipient microorganism and the new microorganism to the level of strain, as appropriate. In lieu of data, EPA will accept a letter from a culture collection substantiating taxonomy, provided EPA, upon request to the submitter, may have access to the data supporting the taxonomic designation. (ii) Information on the morphological and physiological features of the new microorganism. (iii) Other specific data by which the new microorganism may be uniquely identified for Inventory purposes… | ||||
| 40:40:34.0.1.1.2.4.1.6 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | D | Subpart D—Microbial Commercial Activities Notification Requirements | § 725.160 Submission of health and environmental effects data. | EPA | (a) Test data on the new microorganism in the possession or control of the submitter. (1) Except as provided in § 725.25(h), and in addition to the information required by § 725.155(d)(3), each MCAN must contain all test data in the submitter's possession or control which are related to the effects on health or the environment of any manufacture, processing, distribution in commerce, use, or disposal of the new microorganism or any microbial mixture or article containing the new microorganism, or any combination of such activities. This includes test data concerning the new microorganism in a pure culture or formulated form as used or as intended to be used in one of the activities listed above. (2) A full report or standard literature citation must be submitted for the following types of test data: (i) Health effects data. (ii) Ecological effects data. (iii) Physical and chemical properties data. (iv) Environmental fate characteristics. (v) Monitoring data and other test data related to human exposure to or environmental release of the new microorganism. (3)(i) If the data do not appear in the open scientific literature, the submitter must provide a full report. A full report includes the experimental methods and materials, results, discussion and data analysis, conclusions, references, and the name and address of the laboratory that developed the data. (ii) If the data appear in the open scientific literature, the submitter need only provide a standard literature citation. A standard literature citation includes author, title, periodical name, date of publication, volume, and page numbers. (4)(i) If a study, report, or test is incomplete when a person submits a MCAN, the submitter must identify the nature and purpose of the study; name and address of the laboratory developing the data; progress to date; types of data collected, significant preliminary results; and anticipated completion date. (ii) If a test or experiment is completed before the MCAN review period ends, the person must submit the stu… | ||||
| 40:40:34.0.1.1.2.4.1.7 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | D | Subpart D—Microbial Commercial Activities Notification Requirements | § 725.170 EPA review of the MCAN. | EPA | [62 FR 17932, Apr. 11, 1997, as amended by 89 FR 102799, Dec. 18, 2024] | General procedures for review of all submissions under this part are contained in §§ 725.28 through 725.60. In addition, the following procedures apply to EPA review of MCANs submitted under this subpart: (a) Length of the review period. The MCAN review period specified in section 5(a) of the Act runs for 90 days from the date EPA receives a complete MCAN, or the date EPA determines the MCAN is complete under § 725.33, unless the Agency extends the period under section 5(c) of the Act and § 725.56. (b) Determinations. (1) Within the applicable review period, EPA will make one of the following five determinations on the microorganism, as set forth in section 5(a)(3) of the Act: (i) The microorganism presents an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(A) of the Act. (ii) Information available to EPA is insufficient to permit a reasoned evaluation of the health and the environmental effects of the microorganism, as set forth in section 5(a)(3)(B)(i) of the Act. (iii) In the absence of sufficient information to permit EPA to make such an evaluation, the microorganism may present an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(B)(ii)(I) of the Act. (iv) The microorganism is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance, as set forth in section 5(a)(3)(B)(ii)(II) of the Act. (v) The microorganism is not likely to present an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(C) of the Act. (2) EPA will take the following actions required in association with the determination. (i) For determinations described in paragraph (b)(1)(i) of this section, EPA will issue the submitter an order to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of t… | |||
| 40:40:34.0.1.1.2.4.1.8 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | D | Subpart D—Microbial Commercial Activities Notification Requirements | § 725.190 Notice of commencement of manufacture or import. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013; 88 FR 37174, June 7, 2023] | (a) Applicability. Any person who commences the manufacture or import of a new microorganism for nonexempt, commercial purposes for which that person previously submitted a section 5(a) notice under this part must submit a notice of commencement (NOC) of manufacture or import. (b) When to report. (1) If manufacture or import for nonexempt, commercial purposes begins on or after May 27, 1997, the submitter must submit the NOC to EPA no later than 30 calendar days after the first day of such manufacture or import. (2) If manufacture or import for nonexempt, commercial purposes began or will begin before May 27, 1997, the submitter must submit the NOC by May 27, 1997. (3) Submission of an NOC prior to the commencement of manufacture or import is a violation of section 15 of the Act. (c) Information to be reported. The NOC must contain the following information: Specific microorganism identity, MCAN number, and the date when manufacture or import commences. If the person claims any information on the form as confidential, the claim must be asserted and substantiated in accordance with the requirements described in part 703 of this subchapter and § 725.80, as indicated in EPA Form 7710-56. If the submitter wants the microorganism identity to be listed on the confidential portion of the TSCA Inventory, the microorganism identity must be claimed as confidential and also follow the certification, substantiation, and generic name requirements described in part 703 of this subchapter and paragraphs (e) and (f) of this section. (d) How to submit. All notices of commencement must be generated, completed, and submitted to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software. (e) Requirements for assertion. Any person who asserts a confidentiality claim for microorganism identity must: (1) Comply with the requirements of paragraph (f) of this section regarding submission of a generic name. (2) Agree that EPA may disclose to a person with a bona fide … | |||
| 40:40:34.0.1.1.2.5.1.1 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.200 Scope and purpose. | EPA | (a) This subpart describes exemptions from the reporting requirements under subpart D of this part for research and development activities involving microorganisms. (b) In lieu of complying with subpart D of this part, persons described in § 725.205 may submit a TSCA Experimental Release Application (TERA) for research and development activities involving microorganisms or otherwise comply with this subpart. (c) Exemptions from part 725 are provided at §§ 725.232, 725.234, and 725.238. (d) Submission requirements specific for TERAs are described at § 725.250. (e) Data requirements for TERAs are set forth in §§ 725.255 and 725.260. (f) EPA review procedures specific for TERAs are set forth in §§ 725.270 and 725.288. (g) Subparts A through C of this part apply to any submission under this subpart. | ||||
| 40:40:34.0.1.1.2.5.1.10 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.260 Submission of health and environmental effects data. | EPA | Each TERA must contain all available data concerning actual or potential effects on health or the environment of the new microorganism that are in the possession or control of the submitter and a description of other data known to or reasonably ascertainable by the submitter that will permit a reasoned evaluation of the planned test in the environment. The data must be reported in the manner described in § 725.160(a)(3) and (b)(3). | ||||
| 40:40:34.0.1.1.2.5.1.11 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.270 EPA review of the TERA. | EPA | General procedures for review of all submissions under this part are contained in §§ 725.28 through 725.60. In addition, the following procedures apply to EPA review of applications submitted under this subpart: (a) Length of the review period. (1) The review period for the TERA will be 60 days from the date the Document Control Officer for the Office of Pollution Prevention and Toxics receives a complete TERA, or the date EPA determines the TERA is complete under § 725.33, unless EPA finds good cause for an extension under § 725.56. (2) A submitter shall not proceed with the research and development activity described in the TERA unless and until EPA provides written approval of the TERA. A submitter may receive early approval if a review is completed in less than 60 days. (b) EPA decision regarding proposed TERA activity. (1) A decision concerning a TERA under this subpart will be made by the Administrator, or a designee. (2) If EPA determines that the proposed research and development activity for the microorganism does not present an unreasonable risk of injury to health or the environment, EPA will notify the submitter that the TERA is approved and that the submitter can proceed with the proposed research and development activity described in the TERA. (3) EPA may include requirements and conditions in its approval of the TERA that would be stated in the TERA approval under paragraph (c) of this section. (4) If EPA concludes that it cannot determine that the proposed research and development activity described in the TERA will not present an unreasonable risk of injury to health or the environment, EPA will deny the TERA and will provide reasons for the denial in writing. (c) TERA approval. (1) A TERA approval issued by EPA under this section is legally binding on the TERA submitter. (2) When EPA approves a TERA, the submitter must conduct the research and development activity only as described in the TERA and in accordance with any requirements and conditions prescribed by EPA in its approval … | ||||
| 40:40:34.0.1.1.2.5.1.12 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.288 Revocation or modification of TERA approval. | EPA | (a) Significant questions about risk. (1) If, after approval of a TERA under this subpart, EPA receives information which raises significant questions about EPA's determination that the activity does not present an unreasonable risk of injury to health or the environment, EPA will notify the submitter in writing of those questions. (2) The submitter may, within 10 days of receipt of EPA's notice, provide in writing additional information or arguments concerning the significance of the questions and whether EPA should modify or revoke the approval of the TERA. (3) After considering any such information and arguments, EPA will decide whether to change its determination regarding approval of the TERA. (i) If EPA determines that the activity will not present an unreasonable risk of injury to health or the environment, it will notify the submitter in writing. To make this finding, EPA may prescribe additional conditions which must be followed by the submitter. (ii) If EPA determines that it can no longer conclude that the activity will not present an unreasonable risk of injury to health or the environment, it will notify the submitter in writing that EPA is revoking its approval and state its reasons. In that event, the submitter must terminate the research and development activity within 48 hours of receipt of the notice in accordance with directions provided by EPA in the notice. (b) Evidence of unreasonable risk. (1) If, after approval of a TERA under this subpart, EPA determines that the proposed research and development activity will present an unreasonable risk of injury to health or the environment, EPA will notify the submitter in writing and state its reasons. (2) In the notice, EPA may prescribe additional safeguards to address or reduce the risk, or may instruct the submitter to suspend the research and development activities. (3) Within 48 hours, the submitter must implement the instructions contained in the notice. The submitter may then submit additional information or arguments concerning th… | ||||
| 40:40:34.0.1.1.2.5.1.2 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.205 Persons who may report under this subpart. | EPA | (a) Commercial research and development activities involving new microorganisms or significant new uses of microorganisms are subject to reporting under this part unless they qualify for an exemption under this part. (b) Commercial purposes for research and development means that the activities are conducted with the purpose of obtaining an immediate or eventual commercial advantage for the researcher and would include: (1) All research and development activities which are funded directly, in whole or in part, by a commercial entity regardless of who is actually conducting the research. Indications that the research and development activities are funded directly, in whole or in part, may include, but are not limited to: (i) Situations in which a commercial entity contracts directly with a university or researcher; or (ii) Situations in which a commercial entity gives a conditional grant where the commercial entity holds patent rights, or establishes a joint venture where the commercial entity holds patent or licensing rights; or (iii) Any other situation in which the commercial entity intends to obtain an immediate or eventual commercial advantage for the commercial entity and/or the researcher. (2) Research and development activities that are not funded directly by a commercial entity, if the researcher intends to obtain an immediate or eventual commercial advantage. Indications that the researcher intends to obtain an immediate or eventual commercial advantage may include, but are not limited to: (i) The research is directed toward developing a commercially viable improvement of a product already on the market; or (ii) The researcher has sought or is seeking commercial funding for the purpose of developing a commercial application; or (iii) The researcher or university has sought or is seeking a patent to protect a commercial application which the research is developing; or (iv) Other evidence that the researcher is aware of a commercial application for the research and has directed the research towar… | ||||
| 40:40:34.0.1.1.2.5.1.3 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.232 Activities subject to the jurisdiction of other Federal programs or agencies. | EPA | This part does not apply to any research and development activity that meets all of the following conditions. (a) The microorganism is manufactured, imported, or processed solely for research and development activities. (b) There is no intentional testing of a microorganism outside of a structure, as structure is defined in § 725.3. (c)(1) The person receives research funds from another Federal agency, and the funds are awarded on the condition that the research will be conducted in accordance with the relevant portions of the NIH Guidelines, or (2) A Federal agency or program otherwise imposes the legally binding requirement that the research is to be conducted in accordance with relevant portions of the NIH Guidelines. | ||||
| 40:40:34.0.1.1.2.5.1.4 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.234 Activities conducted inside a structure. | EPA | A person who manufactures, imports, or processes a microorganism is not subject to the reporting requirements under subpart D of this part if all of the following conditions are met: (a) The microorganism is manufactured, imported, or processed solely for research and development activities. (b) The microorganism is used by, or directly under the supervision of, a technically qualified individual, as defined in § 725.3. The technically qualified individual must maintain documentation of the procedures selected to comply with paragraph (d) of this section and must ensure that the procedures are used. (c) There is no intentional testing of a microorganism outside of a structure, as structure is defined in § 725.3. (d) Containment and/or inactivation controls. (1) Selection and use of containment and/or inactivation controls inside a structure for a particular microorganism shall take into account the following: (i) Factors relevant to the organism's ability to survive in the environment. (ii) Potential routes of release in air, solids and liquids; in or on waste materials and equipment; in or on people, including maintenance and custodial personnel; and in or on other organisms, such as insects and rodents. (iii) Procedures for transfer of materials between facilities. (2) The technically qualified individual's selection of containment and/or inactivation controls shall be approved and certified by an authorized official (other than the TQI) of the institution that is conducting the test prior to the commencement of the test. (3) Records shall be developed and maintained describing the selection and use of containment and/or inactivation controls, as specified in § 725.235(c). These records, which must be maintained at the location where the research and development activity is being conducted, shall be submitted to EPA upon written request and within the time frame specified in EPA's request. (4) Subsequent to EPA review of records in accordance with paragraph (d)(3) of this section, changes to the conta… | ||||
| 40:40:34.0.1.1.2.5.1.5 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.235 Conditions of exemption for activities conducted inside a structure. | EPA | (a) Determination of risks. To determine whether notification under § 725.234(e) is required, the manufacturer, importer, or processor must do one of the following: (1) For research conducted in accordance with the NIH Guidelines, the manufacturer, importer, or processor must meet the conditions laid out at IV-B-4-d of the NIH Guidelines; or (2) For all other research conducted in accordance with § 725.234, the manufacturer, importer, or processor must review and evaluate the following information to determine whether there is reason to believe there is any risk to health which may be associated with the microorganism: (i) Information in its possession or control concerning any significant adverse reaction of persons exposed to the microorganism which may reasonably be associated with such exposure. (ii) Information provided to the manufacturer, importer, or processor by a supplier or any other person concerning a health risk believed to be associated with the microorganism. (iii) Health and environmental effects data in its possession or control concerning the microorganism. (iv) Information on health effects which accompanies any EPA rule or order issued under TSCA section 4, 5, or 6 of the Act that applies to the microorganism and of which the manufacturer, importer, or processor has knowledge. (b) Notification to employees and others. (1) The manufacturer, importer, or processor must notify the persons identified in § 725.234(e) by means of a container labeling system, conspicuous placement of notices in areas where exposure may occur, written notification to each person potentially exposed, or any other method of notification which adequately informs persons of health risks which the manufacturer, importer, or processor has reason to believe may be associated with the microorganism, as determined under paragraph (a) of this section. (2) If the manufacturer, importer, or processor distributes a microorganism manufactured, imported, or processed under this section to persons not in its employ, the … | ||||
| 40:40:34.0.1.1.2.5.1.6 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.238 Activities conducted outside a structure. | EPA | (a) Exemption. (1) Research and development activities involving intentional testing in the environment of certain microorganisms listed in § 725.239 may be conducted without prior review by EPA if all of the conditions of this section and § 725.239 are met. (2) The research and development activity involving a microorganism listed in § 725.239 must be conducted by, or directly under the supervision of, a technically qualified individual, as defined in § 725.3. (b) Certification. To be eligible for the exemption under this section, a manufacturer or importer must submit to EPA prior to initiation of the activity a document signed by an authorized official containing the following information: (1) Name, address, and telephone number of the manufacturer or importer. (2) Location, estimated duration, and planned start date of the test. (3) Certification of the following: (i) Compliance with the conditions of the exemption specified for the microorganism in § 725.239. (ii) If state and/or local authorities have been notified of the activity, evidence of notification. (c) Recordkeeping. Persons who conduct research and development activities under this section must comply with the recordkeeping requirements of § 725.65 and retain documentation that supports their compliance with the requirements of this section and the specific requirements for the microorganism listed in § 725.239. | ||||
| 40:40:34.0.1.1.2.5.1.7 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.239 Use of specific microorganisms in activities conducted outside a structure. | EPA | (a) Bradyrhizobium japonicum. To qualify for an exemption under this section, all of the following conditions must be met for a test involving Bradyrhizobium japonicum: (1) Characteristics of recipient microorganism. The recipient microorganism is limited to strains of Bradyrhizobium japonicum. (2) Modification of traits. (i) The introduced genetic material must meet the criteria for poorly mobilizable listed in § 725.421(c). (ii) The introduced genetic material must consist only of the following components: (A) The structural gene(s) of interest, which have the following limitations: ( 1 ) For structural genes encoding marker sequences, the gene is limited to the aadH gene, which confers resistance to the antibiotics streptomycin and spectinomycin. ( 2 ) For traits other than antibiotic resistance, the structural gene must be limited to the genera Bradyrhizobium and Rhizobium. (B) The regulatory sequences permitting the expression of solely the gene(s) of interest. (C) Associated nucleotide sequences needed to move genetic material, including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites. (D) The vector nucleotide sequences needed for vector transfer. (E) The vector nucleotide sequences needed for vector maintenance. (3) Limitations on exposure. (i) The test site area must be no more than 10 terrestrial acres. (ii) The technically qualified individual must select appropriate methods to limit the dissemination of modified Bradyrhizobium japonicum. (b) Rhizobium meliloti. To qualify for an exemption under this section, all of the following conditions must be met for a test involving Rhizobium meliloti: (1) Characteristics of recipient microorganism. The recipient microorganism is limited to strains of Rhizobium meliloti. (2) Modification of traits. (i) The introduced genetic material must meet the criteria for poorly mobilizable listed in § 725.421(c) of this part. (ii) The introduced genetic material must consist only of the… | ||||
| 40:40:34.0.1.1.2.5.1.8 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.250 Procedural requirements for the TERA. | EPA | General requirements for all submissions under this part are contained in subparts A through C of this part. In addition, the following requirements apply to TERAs submitted under this subpart: (a) When to submit the TERA. Each person who is eligible to submit a TERA under this subpart must submit the TERA at least 60 calendar days before the person intends to initiate the proposed research and development activity. (b) Contents of the TERA. Each person who submits a TERA under this subpart must provide the information and test data described in §§ 725.255 and 725.260. In addition, the submitter must supply sufficient information to enable EPA to evaluate the effects of all activities for which approval is requested. (c) A person may submit a TERA for one or more microorganisms and one or more research and development activities, including a research program. (d) EPA will either approve the TERA, with or without conditions, or disapprove it under procedures established in this subpart. (e) The manufacturer, importer, or processor who receives a TERA approval must comply with all terms of the approval, as well as conditions described in the TERA, and remains liable for compliance with all terms and conditions, regardless of who conducts the research and development activity. Any person conducting the research and development activity approved under the TERA must comply with all terms of the TERA approval, as well as the conditions described in the TERA. (f) Recordkeeping. Persons submitting a TERA must comply with the recordkeeping requirements of § 725.65. In addition, the following requirements apply to TERAs: (1) Each person submitting a TERA under this part must retain documentation of information contained in the TERA for a period of 3 years from the date that the results of the study are submitted to the Agency. (2) Summaries of all data, conclusions, and reports resulting from the conduct of the research and development activity under the TERA must be submitted to the EPA address identified in… | ||||
| 40:40:34.0.1.1.2.5.1.9 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | E | Subpart E—Exemptions for Research and Development Activities | § 725.255 Information to be included in the TERA. | EPA | (a) To review a TERA, EPA must have sufficient information to permit a reasoned evaluation of the health and environmental effects of the planned test in the environment. The person seeking EPA approval must submit all information known to or reasonably ascertainable by the submitter on the microorganism(s) and the research and development activity, including information not listed in paragraphs (c), (d), and (e) of this section that the person believes will be useful for EPA's risk assessment. The TERA must be in writing and must include at least the information described in the following paragraphs. (b) When specific information is not submitted, an explanation of why such information is not available or not applicable must be included. (c) Persons applying for a TERA, must include the submitter identification and microorganism identity information required for MCANs in § 725.155(c), (d)(1), and (d)(2). (d) Persons applying for a TERA must submit phenotypic and ecological characteristics information required in § 725.155(d)(3) as it relates directly to the conditions of the proposed research and development activity. (e) Persons applying for a TERA must also submit the following information about the proposed research and development activity: (1) A detailed description of the proposed research and development activity. (i) The objectives and significance of the activity and a rationale for testing the microorganisms in the environment. (ii) Number of microorganisms released (including viability per volume if applicable) and the method(s) of application or release. (iii) Characteristics of the test site(s), including location, geographical, physical, chemical, and biological features, proximity to human habitation or activity, and description of site characteristics that would influence dispersal or confinement. (iv) Target organisms (if the microorganism(s) to be tested has an intended target), including identification of each target organism and anticipated mechanism and result of interaction. (v) … | ||||
| 40:40:34.0.1.1.2.6.1.1 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | F | Subpart F—Exemptions for Test Marketing | § 725.300 Scope and purpose. | EPA | (a) This subpart describes exemptions from the reporting requirements under subpart D of this part for test marketing activities involving microorganisms. (b) In lieu of complying with subpart D of this part, persons described in § 725.305 may submit an application for a test marketing exemption (TME). (c) Submission requirements specific for TME applications are described at § 725.350. (d) Data requirements for TME applications are set forth in § 725.355. (e) EPA review procedures specific for TMEs are set forth in § 725.370. (f) Subparts A through C of this part apply to any submission under this subpart. | ||||
| 40:40:34.0.1.1.2.6.1.2 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | F | Subpart F—Exemptions for Test Marketing | § 725.305 Persons who may apply under this subpart. | EPA | A person identified in this section may apply for a test marketing exemption. EPA may grant the exemption if the person demonstrates that the microorganism will not present an unreasonable risk of injury to health or the environment as a result of the test marketing. A person may apply under this subpart for the following test marketing activities: (a) A person who intends to manufacture or import for commercial purposes a new microorganism. (b) A person who intends to manufacture, import, or process for commercial purposes a microorganism identified in subpart M of this part for a significant new use. | ||||
| 40:40:34.0.1.1.2.6.1.3 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | F | Subpart F—Exemptions for Test Marketing | § 725.350 Procedural requirements for this subpart. | EPA | General requirements for all submissions under this part are contained in subparts A through C of this part. In addition, the following requirements apply to applications submitted under this subpart: (a) Prenotice consultation. EPA strongly suggests that for a TME, the applicant contact EPA for a prenotice consultation regarding eligibility for a TME. (b) When to submit a TME application. Each person who is eligible to apply for a TME under this subpart must submit the application at least 45 calendar days before the person intends to commence the test marketing activity. (c) Recordkeeping. Each person who is granted a TME must comply with the recordkeeping requirements of § 725.65. In addition, any person who obtains a TME must retain documentation of compliance with any restrictions imposed by EPA when it grants the TME. This information must be retained for 3 years from the final date of manufacture or import under the exemption. | ||||
| 40:40:34.0.1.1.2.6.1.4 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | F | Subpart F—Exemptions for Test Marketing | § 725.355 Information to be included in the TME application. | EPA | (a) To review a TME application, EPA must have sufficient information to permit a reasoned evaluation of the health and environmental effects of the planned test marketing activity. The person seeking EPA approval must submit all information known to or reasonably ascertainable by the person on the microorganism and the test marketing activity, including information not listed in paragraphs (c), (d), and (e) of this section that the person believes will demonstrate that the microorganism will not present an unreasonable risk of injury to health or the environment as a result of the test marketing. The TME application must be in writing and must include at least the information described in paragraphs (b), (c), (d), and (e) of this section. (b) When specific information is not submitted, an explanation of why such information is not available or not applicable must be included. (c) Persons applying for a TME must submit the submitter identification and microorganism identity information required for MCANs in § 725.155(c), (d)(1), and (d)(2). (d) Persons applying for a TME must submit phenotypic and ecological characteristics information required in § 725.155(d)(3) as it relates directly to the conditions of the proposed test marketing activity. (e) Persons applying for a TME must also submit the following information about the proposed test marketing activity: (1) Proposed test marketing activity. (i) The maximum quantity of the microorganism which the applicant will manufacture or import for test marketing. (ii) The maximum number of persons who may be provided the microorganism during test marketing. (iii) The maximum number of persons who may be exposed to the microorganism as a result of test marketing, including information regarding duration and route of such exposures. (iv) A description of the test marketing activity, including its duration and how it can be distinguished from full-scale commercial production and research and development activities. (2) Health and environmental effects data. A… | ||||
| 40:40:34.0.1.1.2.6.1.5 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | F | Subpart F—Exemptions for Test Marketing | § 725.370 EPA review of the TME application. | EPA | General procedures for review of all submissions under this part are contained in §§ 725.28 through 725.60. In addition, the following procedures apply to EPA review of TME applications submitted under this subpart: (a) No later than 45 days after EPA receives a TME, the Agency will either approve or deny the application. (b) A submitter may only proceed with test marketing activities after receipt of EPA approval. (c) In approving a TME application, EPA may impose any restrictions necessary to ensure that the microorganism will not present an unreasonable risk of injury to health and the environment as a result of test marketing. | ||||
| 40:40:34.0.1.1.2.7.1.1 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | G | Subpart G—General Exemptions for New Microorganisms | § 725.400 Scope and purpose. | EPA | (a) This subpart describes exemptions from reporting under subpart D of this part, and from review under this part altogether, for manufacturing and importing of certain new microorganisms for commercial purposes. (b) Recipient microorganisms eligible for the tiered exemption from review under this part are listed in § 725.420. (c) Criteria for the introduced genetic material contained in the new microorganisms are described in § 725.421. (d) Physical containment and control technologies are described in § 725.422. (e) The conditions for the Tier I exemption are listed in § 725.424. (f) In lieu of complying with subpart D of this part, persons using recipient microorganisms eligible for the tiered exemption may submit a Tier II exemption request. The limited reporting requirements for the Tier II exemption, including data requirements, are described in §§ 725.450 and 725.455. (g) EPA review procedures for the Tier II exemption are set forth in § 725.470. (h) Subparts A through C of this part apply to any submission under this subpart. | ||||
| 40:40:34.0.1.1.2.7.1.10 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | G | Subpart G—General Exemptions for New Microorganisms | § 725.470 EPA review of the Tier II exemption request. | EPA | General procedures for review of all submissions under this part are contained in §§ 725.28 through 725.60. In addition, the following procedures apply to EPA review of Tier II exemption requests submitted under this subpart: (a) Length of the review period. The review period for the request will be 45 days from the date the Document Control Officer for the Office of Pollution Prevention and Toxics receives a complete request, or the date EPA determines the request is complete under § 725.33, unless the Agency extends the review period for good cause under § 725.56. (b) Criteria for review. EPA will review the request to determine that the new microorganism complies with § 725.428 and that its manufacture, processing, use, and disposal as described in the request will not present an unreasonable risk of injury to health or the environment. (c) EPA decision regarding the Tier II exemption request. A decision concerning a request under this subpart will be made by the Administrator, or a designee. (d) Determination that the microorganism is ineligible for a Tier II review. (1) EPA may determine that the manufacturer or importer is not eligible for Tier II review, because the microorganism does not meet the criteria under § 725.428 or the Administrator, or a designee, decides that there is insufficient information to determine that the conditions of manufacture, processing, use, or disposal of the microorganism as described in the request will not present an unreasonable risk to health or the environment. (2) If the Agency makes this determination, the Administrator, or a designee will notify the manufacturer or importer by telephone, followed by a letter, that the request has been denied. The letter will explain reasons for the denial. (3) If the request is denied, the manufacturer or importer may submit the information necessary to constitute a MCAN under subpart D of this part. (e) Approval or denial of the Tier II exemption request. (1) No later than 45 days after EPA receives a request, the Age… | ||||
| 40:40:34.0.1.1.2.7.1.2 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | G | Subpart G—General Exemptions for New Microorganisms | § 725.420 Recipient microorganisms. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 85 FR 13772, Mar. 10, 2020] | The following recipient microorganisms are eligible for either exemption under this subpart: (a) Acetobacter aceti. (b) Aspergillus niger. (c) Aspergillus oryzae. (d) Bacillus licheniformis. (e) Bacillus subtilis. (f) Clostridium acetobutylicum. (g) Escherichia coli K-12. (h) Penicillium roqueforti. (i) Saccharomyces cerevisiae. (j) Saccharomyces uvarum. (k) Trichoderma reesei strain QM6a and its derivatives used only in submerged standard industrial fermentation operations as defined at 40 CFR 725.3. (l) Bacillus amyloliquefaciens subsp. amyloliquefaciens. | |||
| 40:40:34.0.1.1.2.7.1.3 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | G | Subpart G—General Exemptions for New Microorganisms | § 725.421 Introduced genetic material. | EPA | For a new microorganism to qualify for either exemption under this subpart, introduced genetic material must meet all of the criteria listed in this section. (a) Limited in size. The introduced genetic material must consist only of the following: (1) The structural gene(s) of interest. (2) The regulatory sequences permitting the expression of solely the gene(s) of interest. (3) Associated nucleotide sequences needed to move genetic material, including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites. (4) The nucleotide sequences needed for vector transfer. (5) The nucleotide sequences needed for vector maintenance. (b) Well-characterized. For introduced genetic material, well-characterized means that the following have been determined: (1) The function of all of the products expressed from the structural gene(s). (2) The function of sequences that participate in the regulation of expression of the structural gene(s). (3) The presence or absence of associated nucleotide sequences and their associated functions, where associated nucleotide sequences are those sequences needed to move genetic material including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites. (c) Poorly mobilizable. The ability of the introduced genetic material to be transferred and mobilized is inactivated, with a resulting frequency of transfer of less than 10 −8 transfer events per recipient. (d) Free of certain sequences. (1) The introduced genetic material must not contain a functional portion of any of the toxin-encoding sequences described in this paragraph (d). (i) For the purposes of this section, a functional portion of a toxin-encoding sequence means any sequence which codes for a polypeptide that has one of the following effects: (A) It directly or indirectly contributes to toxic effects in humans. Directly contributes to toxic effects in humans means those sequences encoding polypeptides that have direct toxicity to tar… | ||||
| 40:40:34.0.1.1.2.7.1.4 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | G | Subpart G—General Exemptions for New Microorganisms | § 725.422 Physical containment and control technologies. | EPA | The manufacturer must meet all of the following criteria for physical containment and control technologies for any facility in which the new microorganism will be used for a Tier I exemption; these criteria also serve as guidance for a Tier II exemption. (a) Use a structure that is designed and operated to contain the new microorganism. (b) Control access to the structure. (c) Provide written, published, and implemented procedures for the safety of personnel and control of hygiene. (d) Use inactivation procedures demonstrated and documented to be effective against the new microorganism contained in liquid and solid wastes prior to disposal of the wastes. The inactivation procedures must reduce viable microbial populations by at least 6 logs in liquid and solid wastes. (e) Use features known to be effective in minimizing viable microbial populations in aerosols and exhaust gases released from the structure, and document use of such features. (f) Use systems for controlling dissemination of the new microorganism through other routes, and document use of such features. (g) Have in place emergency clean-up procedures. | ||||
| 40:40:34.0.1.1.2.7.1.5 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | G | Subpart G—General Exemptions for New Microorganisms | § 725.424 Requirements for the Tier I exemption. | EPA | (a) Conditions of exemption. The manufacture or import of a new microorganism for commercial purposes is not subject to review under this part if all of the following conditions are met for all activities involving the new microorganism: (1) The recipient microorganism is listed in and meets any requirements specified in § 725.420. (2) The introduced genetic material meets the criteria under § 725.421. (3) The physical containment and control technologies of any facility in which the microorganism will be manufactured, processed, or used meet the criteria under § 725.422. (4) The manufacturer or importer submits a certification described in paragraph (b) of this section to EPA at least 10 days before commencing initial manufacture or import of a new microorganism derived from a recipient microorganism listed in § 725.420. (5) The manufacturer or importer complies with the recordkeeping requirements of § 725.65 and maintains records for the initial and subsequent uses of the new microorganism that verify compliance with the following: (i) The certifications made in paragraph (b) of this section. (ii) All the eligibility criteria for the Tier I exemption including the criteria for the recipient microorganism, the introduced genetic material, the physical containment and control technologies. (b) Certification. To be eligible for the Tier I exemption under this subpart, the manufacturer or importer must submit to EPA a document signed by a responsible company official containing the information listed in this paragraph. (1) Name and address of manufacturer or importer. (2) Date when manufacture or import is expected to begin. (3) The identification (genus, species) of the recipient microorganism listed in § 725.420 which is being used to create the new microorganism which will be used under the conditions of the Tier I exemption. (4) Certification of the following: (i) Compliance with the introduced genetic material criteria described in § 725.421. (ii) Compliance with the containment requirements … | ||||
| 40:40:34.0.1.1.2.7.1.6 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | G | Subpart G—General Exemptions for New Microorganisms | § 725.426 Applicability of the Tier I exemption. | EPA | The Tier I exemption under § 725.424 applies only to a manufacturer or importer of a new microorganism that certifies that the microorganism will be used in all cases in compliance with §§ 725.420, 725.421, and 725.422. | ||||
| 40:40:34.0.1.1.2.7.1.7 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | G | Subpart G—General Exemptions for New Microorganisms | § 725.428 Requirements for the Tier II exemption. | EPA | The manufacturer or importer of a new microorganism for commercial purposes may submit to EPA a Tier II exemption request in lieu of a MCAN under subpart D of this part if all of the following conditions are met: (a) The recipient microorganism is listed in and meets any requirements specified in § 725.420. (b) The introduced genetic material meets the criteria under § 725.421. (c) Adequate physical containment and control technologies are used. The criteria listed under § 725.422 for physical containment and control technologies of facilities should be used as guidance to satisfy the Tier II exemption request data requirements listed at § 725.455(d). EPA will review proposed process and containment procedures as part of the submission for a Tier II exemption under this section. | ||||
| 40:40:34.0.1.1.2.7.1.8 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | G | Subpart G—General Exemptions for New Microorganisms | § 725.450 Procedural requirements for the Tier II exemption. | EPA | General requirements for all submissions under this part are contained in § 725.25. In addition, the following requirements apply to requests submitted under this subpart: (a) Prenotice consultation. EPA strongly suggests that for a Tier II exemption, the submitter contact the Agency for a prenotice consultation regarding eligibility for the exemption. (b) When to submit the Tier II exemption request. Each person who is eligible to submit a Tier II exemption request under this subpart must submit the request at least 45 calendar days before the person intends to commence manufacture or import. (c) Contents of the Tier II exemption request. Each person who submits a request under this subpart must provide the information described in §§ 725.428 and 725.455, as well as information known to or reasonably ascertainable by the person that would permit EPA to determine that use of the microorganism, under the conditions specified in the request, will not present an unreasonable risk of injury to health or the environment. (d) Recordkeeping. Each person who submits a request under this subpart must comply with the recordkeeping requirements of § 725.65. In addition, the submitter should maintain records which contain information that verifies compliance with the following: (1) The certifications made in the request. (2) All the eligibility criteria for the Tier II exemption request including the criteria for the recipient microorganism, the introduced genetic material, the physical containment and control technologies. | ||||
| 40:40:34.0.1.1.2.7.1.9 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | G | Subpart G—General Exemptions for New Microorganisms | § 725.455 Information to be included in the Tier II exemption request. | EPA | The submitter must indicate clearly that the submission is a Tier II exemption request for a microorganism instead of the MCAN under subpart D of this part and must submit the following information: (a) Submitter identification. (1) The name and headquarters address of the submitter. (2) The name, address, and office telephone number (including area code) of the principal technical contact representing the submitter. (b) Microorganism identity information. (1) Identification (genus, species, and strain) of the recipient microorganism. Genus, species designation should be substantiated by a letter from a culture collection or a brief summary of the results of tests conducted for taxonomic identification. (2) Type of genetic modification and the function of the introduced genetic material. (3) Site of insertion. (4) Certification of compliance with the introduced genetic material criteria described in § 725.421. (c) Production volume. Production volume, including total liters per year, and the maximum cell concentration achieved during the production process. (d) Process and containment information. (1) A description of the process including the following: (i) Identity and location of the manufacturing site(s). (ii) Process flow diagram illustrating the production process, including downstream separations, and indicating the containment envelope around the appropriate equipment. (iii) Identities and quantities of feedstocks. (iv) Sources and quantities of potential releases to both the workplace and environment, and a description of engineering controls, inactivation procedures, and other measures which will reduce worker exposure and environmental releases. (v) A description of procedures which will be undertaken to prevent fugitive emissions, i.e. leak detection and repair program. (vi) A description of procedures/safeguards to prevent and mitigate accidental releases to the workplace and the environment. (2) Certification of those elements of the containment criteria described in § 725.422… | ||||
| 40:40:34.0.1.1.2.9.1.1 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | L | Subpart L—Additional Procedures for Reporting on Significant New Uses of Microorganisms | § 725.900 Scope and purpose. | EPA | (a) This subpart describes additional provisions governing submission of MCANs for microorganisms subject to significant new use rules identified in subpart M of this part. (b) Manufacturers, importers, and processors described in § 725.105(c) must submit a MCAN under subpart D of this part for significant new uses of microorganisms described in subpart M of this part, unless they are excluded under § 725.910 or § 725.912. (c) Section 725.920 discusses exports and imports. (d) Additional recordkeeping requirements specific to significant new uses of microorganisms are described in § 725.950. (e) Section 725.975 describes how EPA will approve alternative means of complying with significant new use requirements designated in subpart M of this part. (f) Expedited procedures for promulgating significant new use requirements under subpart M of this part for microorganisms subject to section 5(e) orders are discussed in §§ 725.980 and 725.984. (g) This subpart L contains provisions governing submission and review of notices for the microorganisms and significant new uses identified in subpart M of this part. The provisions of this subpart L apply to the microorganisms and significant new uses identified in subpart M of this part, except to the extent that they are specifically modified or supplanted by specific requirements in subpart M of this part. In the event of a conflict between the provisions of this subpart L and the provisions of subpart M of this part, the provisions of subpart M of this part shall govern. (h) The provisions of subparts A through F of this part also apply to subparts L and M of this part. For purposes of subparts L and M of this part, wherever the words “microorganism” or “new microorganism” appear in subparts A through F of this part, it shall mean the microorganism subject to subparts L and M of this part. In the event of a conflict between the provisions of subparts A through F and the provisions of subparts L and M of this part, the provisions of subparts L and M of this part shall… | ||||
| 40:40:34.0.1.1.2.9.1.2 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | L | Subpart L—Additional Procedures for Reporting on Significant New Uses of Microorganisms | § 725.910 Persons excluded from reporting significant new uses. | EPA | (a) A person who intends to manufacture, import, or process a microorganism identified in subpart M of this part and who intends to distribute it in commerce is not required to submit a MCAN under subpart D of this part, if that person can document one or more of the following as to each recipient of the microorganism from that person: (1) That the person has notified the recipient, in writing, of the specific section in subpart M of this part which identifies the microorganism and its designated significant new uses, or (2) That the recipient has knowledge of the specific section in subpart M of this part which identifies the microorganism and its designated significant new uses, or (3) That the recipient cannot undertake any significant new use described in the specific section in subpart M of this part. (b) The manufacturer, importer, or processor described in paragraph (a) of this section must submit a MCAN under subpart D of this part, if such person has knowledge at the time of commercial distribution of the microorganism identified in the specific section in subpart M of this part that a recipient intends to engage in a designated significant new use of that microorganism without submitting a MCAN under this part. (c) A person who processes a microorganism identified in a specific section in subpart M of this part for a significant new use of that microorganism is not required to submit a MCAN if that person can document each of the following: (1) That the person does not know the specific microorganism identity of the microorganism being processed, and (2) That the person is processing the microorganism without knowledge that the microorganism is identified in subpart M of this part. (d)(1) If at any time after commencing distribution in commerce of a microorganism identified in a specific section in subpart M of this part, a person who manufactures, imports, or processes a microorganism described in subpart M of this part and distributes it in commerce has knowledge that a recipient of the microo… | ||||
| 40:40:34.0.1.1.2.9.1.3 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | L | Subpart L—Additional Procedures for Reporting on Significant New Uses of Microorganisms | § 725.912 Exemptions. | EPA | Persons identified in § 725.105(c) are not required to submit a MCAN under subpart D of this part for a microorganism identified in subpart M of this part, unless otherwise specified in a specific section in subpart M, if: (a) The person submits a MCAN for the microorganism prior to the promulgation date of the section in subpart M of this part which identifies the microorganism, and the person receives written notification of compliance from EPA prior to the effective date of such section. The MCAN submitter must comply with any applicable requirement of section 5(b) of the Act. The MCAN must include the information and test data specified in section 5(d)(1) of the Act. For purposes of this exemption, the specific section in subpart M of this part which identifies the microorganism and §§ 725.3, 725.15, 725.65, 725.70, 725.75, 725.100, and 725.900 apply; after the effective date of the section in subpart M of this part which identifies the microorganism, §§ 725.105 and 725.910 apply and § 725.920 continues to apply. EPA will provide the MCAN submitter with written notification of compliance only if one of the following occurs: (1) EPA is unable to make the finding that the activities described in the MCAN will or may present an unreasonable risk of injury to health or the environment under reasonably foreseeable circumstances, or (2) EPA and the person negotiate a consent order under section 5(e) of the Act, such order to take effect on the effective date of the section in subpart M of this part which identifies the microorganism. (b) The person is operating under the terms of a consent order issued under section 5(e) of the Act applicable to that person. If a provision of such section 5(e) order is inconsistent with a specific significant new use identified in subpart M of this part, abiding by the provision of the section 5(e) order exempts the person from submitting a MCAN for that specific significant new use. | ||||
| 40:40:34.0.1.1.2.9.1.4 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | L | Subpart L—Additional Procedures for Reporting on Significant New Uses of Microorganisms | § 725.920 Exports and imports. | EPA | (a) Exports. Persons who intend to export a microorganism identified in subpart M of this part, or in any proposed rule which would amend subpart M of this part, are subject to the export notification provisions of section 12(b) of the Act. The regulations that interpret section 12(b) appear at part 707 of this chapter. (b) Imports. Persons who import a substance identified in a specific section in subpart M of this part are subject to the import certification requirements under section 13 of the Act, which are codified at 19 CFR §§ 12.118 through 12.127 and 127.28(i). The EPA policy in support of the import certification requirements appears at part 707 of this chapter. | ||||
| 40:40:34.0.1.1.2.9.1.5 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | L | Subpart L—Additional Procedures for Reporting on Significant New Uses of Microorganisms | § 725.950 Additional recordkeeping requirements. | EPA | Persons submitting a MCAN for a significant new use of a microorganism must comply with the recordkeeping requirements of § 725.65. In addition, the following requirements apply: (a) At the time EPA adds a microorganism to subpart M of this part, EPA may specify appropriate recordkeeping requirements. Each manufacturer, importer, and processor of the microorganism shall maintain the records for 3 years from the date of their creation. (b) The records required to be maintained under this section may include the following: (1) Records documenting the information contained in the MCAN submitted to EPA. (2) Records documenting the manufacture and importation volume of the microorganism and the corresponding dates of manufacture and import. (3) Records documenting volumes of the microorganism purchased domestically by processors of the microorganism, names and addresses of suppliers and corresponding dates of purchase. (4) Records documenting the names and addresses (including shipment destination address, if different) of all persons outside the site of manufacture or import to whom the manufacturer, importer, or processor directly sells or transfers the microorganism, the date of each sale or transfer, and the quantity of the microorganism sold or transferred on such date. | ||||
| 40:40:34.0.1.1.2.9.1.6 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | L | Subpart L—Additional Procedures for Reporting on Significant New Uses of Microorganisms | § 725.975 EPA approval of alternative control measures. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 75 FR 790, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013] | (a) In certain sections of subpart M of this part, significant new uses for the identified microorganisms are described as the failure to establish and implement programs providing for the use of either: specific measures to control worker exposure to or release of microorganisms which are identified in such sections, or alternative measures to control worker exposure or environmental release which EPA has determined provide substantially the same degree of protection as the specified control measures. Persons who manufacture, import, or process a microorganism identified in such sections and who intend to employ alternative measures to control worker exposure or environmental release must submit a request to EPA for a determination of equivalency before commencing manufacture, import, or processing involving the alternative control measures. (b) Persons submitting a request for a determination of equivalency to EPA under this part must submit the request to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software. Support documents related to these requests must also be submitted to EPA via CDX using e-PMN software. A request for a determination of equivalency must contain: (1) The name of the submitter. (2) The specific identity of the microorganism. (3) The citation for the specific section in subpart M of this part which pertains to the microorganism for which the request is being submitted. (4) A detailed description of the activities involved. (5) The specifications of the alternative worker exposure control measures or environmental release control measures. (6) A detailed analysis explaining why such alternative control measures provide substantially the same degree of protection as the specific control measures identified in the specific section in subpart M of this part which pertains to the microorganism for which the request is being submitted. (7) The data and information described in §§ 725.155 and 725.160. If such data and information h… | |||
| 40:40:34.0.1.1.2.9.1.7 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | L | Subpart L—Additional Procedures for Reporting on Significant New Uses of Microorganisms | § 725.980 Expedited procedures for issuing significant new use rules for microorganisms subject to section 5(e) orders. | EPA | (a) Selection of microorganisms. (1) In accordance with the expedited process specified in this section, EPA will issue significant new use notification requirements for each new microorganism that, after MCAN review under subpart D of this part, becomes subject to a final order issued under section 5(e) of the Act, except for an order that prohibits manufacture and import of the microorganism, unless EPA determines that significant new use notification requirements are not needed for the microorganism. (2) If EPA determines that significant new use notifications requirements are not needed for a microorganism that is subject to a final order issued under section 5(e) of the Act, EPA will issue a notice in the Federal Register explaining why the significant new use requirements are not needed. (b) Designation of requirements. (1) The significant new use notification and other specific requirements will be based on and be consistent with the provisions included in the final order issued for the microorganism under section 5(e) of the Act. EPA may also designate additional activities as significant new uses which will be subject to notification. (2) Significant new use requirements and other specific requirements designated under this section will be listed in subpart M of this part. For each microorganism, subpart M of this part will identify: (i) The microorganism name. (ii) The activities designated as significant new uses. (iii) Other specific requirements applicable to the microorganism, including recordkeeping requirements or any other requirements included in the final section 5(e) order. (c) Procedures for issuing significant new use rules —(1) Possible processes. EPA will issue significant new use rules (SNURs) under this section by one of the following three processes: direct final rulemaking, interim final rulemaking, or notice and comment rulemaking. EPA will use the direct final rulemaking process to issue significant new use rules unless it determines that, in a particular case, one of… | ||||
| 40:40:34.0.1.1.2.9.1.8 | 40 | Protection of Environment | I | R | 725 | PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS | L | Subpart L—Additional Procedures for Reporting on Significant New Uses of Microorganisms | § 725.984 Modification or revocation of certain notification requirements. | EPA | [62 FR 17932, Apr. 11, 1997, as amended at 75 FR 790, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013] | (a) Criteria for modification or revocation. EPA may at any time modify or revoke significant new use notification requirements for a microorganism which has been added to subpart M of this part using the procedures of § 725.980. Such action may be taken under this section if EPA makes one of the following determinations, unless other information shows that the requirements should be retained: (1) Test data or other information obtained by EPA provide a reasonable basis for concluding that activities designated as significant new uses of the microorganism will not present an unreasonable risk of injury to health or the environment. (2) EPA has promulgated a rule under section 4 or 6 of the Act, or EPA or another agency has taken action under another law, for the microorganism that eliminates the need for significant new use notification under section 5(a)(2) of the Act. (3) EPA has received MCANs for some or all of the activities designated as significant new uses of the microorganism and, after reviewing such MCANs, concluded that there is no need to require additional notice from persons who propose to engage in identical or similar activities. (4) EPA has examined new information, or has reexamined the test data or other information supporting its finding under section 5(e)(1)(A)(ii)(I) of the Act and has concluded that a rational basis no longer exists for the findings that activities involving the microorganism may present an unreasonable risk of injury to health or the environment required under section 5(e)(1)(A) of the Act. (5) Certain activities involving the microorganism have been designated as significant new uses pending the completion of testing, and adequate test data developed in accordance with applicable procedures and criteria have been submitted to EPA. (b) Procedures for limitation or revocation. Modification or revocation of significant new use notification requirements for a microorganism that has been added to subpart M of this part using the procedures described in § 725.980 may… |
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