### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS



### Section Contents Subpart A—General Provis ions and Applicability § 725.1 Scope and purpose. § 725.3 Definitions. § 725.8 Coverage of this part. § 725.12 Identification of microorganisms for Inventory and other listing purposes. § 725.15 Determining applicability when microorganism identity or use is confidential or uncertain. § 725.17 Consultation with EPA. Subpart B—Administrative Procedures § 725.20 Scope and purpose. § 725.25 General administrative requirements. § 725.27 Submissions. § 725.28 Notice that submission is not required. § 725.29 EPA ackno wledgement of recei pt of submission. § 725.32 Errors in the submission. § 725.33 Incomplete submissions. § 725.36 New information. § 725.40 Notice in the Federal Register. § 725.50 EPA review. § 725.54 Suspension of the review period. § 725.56 Extension of the review period. § 725.60 Withdrawal of submission by the submitter. § 725.65 Recordkeeping. § 725.67 Applications to exempt new microorganisms from this part. § 725.70 Compliance. § 725.75 Inspections. Subpart C—Confidentiality and Public Access to Information § 725.80 General provisions for confidentiality claims. § 725.85 Microorganism identity. § 725.88 Uses of a microorganism. § 725.92 Data from health and safety studies of microorganisms. § 725.94 Substantiation requirements. § 725.95 Public file. Subpart D—Microbial Commercial Activiti es Notification Requirements § 725.100 Scope and purpose. § 725.105 Persons who must report. § 725.110 Persons not subject to this subpart. § 725.150 Procedural requirements for this subpart. § 725.155 Information to be included in the MCAN. § 725.160 Submission of health and environmental effects data. § 725.170 EPA review of the MCAN. § 725.190 Notice of commencement of manufacture or import. Subpart E—Exemptions for Research and Development Activities § 725.200 Scope and purpose. § 725.205 Persons who may report under this subpart.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 § 725.232 Activities subject to the jurisdiction of other Federal programs or agencies. § 725.234 Activities conducted inside a structure. § 725.235 Conditions of exemption for activities conducted inside a structure. § 725.238 Activities conducted outside a structure. § 725.239 Use of specific microorganisms in activities conducted outside a structure. § 725.250 Procedural requirements for the TERA. § 725.255 Information to be included in the TERA. § 725.260 Submission of health and environmental effects data. § 725.270 EPA review of the TERA. § 725.288 Revocation or modification of TERA approval. Subpart F—Exemptions for Test Marketing § 725.300 Scope and purpose. § 725.305 Persons who may apply under this subpart. § 725.350 Procedural requirements for this subpart. § 725.355 Information to be included in the TME application. § 725.370 EPA review of the TME application. Subpart G—General Exemptions for New Microorganisms § 725.400 Scope and purpose. § 725.420 Recipient microorganisms. § 725.421 Introduced genetic material. § 725.422 Physical containm ent and control technologies. § 725.424 Requirements for the Tier I exemption. § 725.426 Applicability of the Tier I exemption. § 725.428 Requirements for the Tier II exemption. § 725.450 Procedural requiremen ts for the Tier II exemption. § 725.455 Information to be included in the Tier II exemption request. § 725.470 EPA review of the Tier II exemption request. Subparts H–K [Reserved] Subpart L—Additional Procedures for Reporting on Significant New Uses of Microorganisms § 725.900 Scope and purpose. § 725.910 Persons excluded from reporting significant new uses. § 725.912 Exemptions. § 725.920 Exports and imports. § 725.950 Additional recordkeeping requirements. § 725.975 EPA approval of alternative control measures. § 725.980 Expedited procedures for issuing significant new use rules for microorganisms subject to section 5(e) orders. § 725.984 Modification or revocation of certain notification requirements. Subpart M—Significant New Uses for Specific Microorganisms § 725.1000 Scope. § 725.1075 Burkholderia cepacia complex.

Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.

Source: 62 FR 17932, April 11, 1997, unless otherwise noted. 

### Subpart A—General Provisions and Applicability

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 

### § 725.1 Scope and purpose. (a) This part establishes all reporting requirements under section 5 of TSCA for manufacturers, importers, and processors of microorganisms subject to TSCA jurisd iction for commercial purposes, including research and development for commercial purposes. New microorganism s for which manufacturers and importers are required to report under section 5(a)(1)(A) of TSCA are those that ar e 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, im ported, 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) mu st file a Microbial Commercial Activity Notice (MCAN) with EPA, unless the activity is eligible for a sp ecific 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 ar e 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 Invent ory established under section 8 of TSCA once a MCAN has been received, the MCAN review period has expired, and EPA receives a Notice of Commencement (NOC) indicating that manufacture or importation has actuallybegun. New microorganisms approved for use under a TERA will not be added to the Inventory until a MCAN has been received, the MCAN review period has expired, and EPA has received an NOC. 

### § 725.3 Definitions. 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 specif ied in this section. In additi on, 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 unde r subparts E, F, or G of this part.

General commercial use means use for commercial purposes other than research and development.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 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 th e 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 microorgani sm 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 “hea lth 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 data that bear on the effects of a microorganism on health or the environment would be included. (2) Examples include: (i) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, criti cal life stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem (microcosm) studies. (ii) Long- and short-term tests of mutagenicity, carci nogenicity, or teratogenicity; dermatoxicity; cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects. (iii) Assessments of human and environmental expos ure, including workplace exposure, and impacts of a particular microorganism or microbial mixture on the environment, including surveys, tests, and studies of: Survival and transport in air, water, and soil; ability to exchange genetic material with other microorganisms, ability to colonize human or animal guts, and ability to colonize plants. (iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a microorganism. (v) Any assessments of risk to health and the environm ent resulting from the manufacture, processing, distribution in commerce, use, or disposal of the microorganism.

Inactivation means that living microorganisms are rendered nonviable. Institutional Biosafety Committee means the committees described in the NIH Guidelines in section IV.B.2. Intergeneric microorganism means a microorganism that is formed by the deliberate combination of genetic material originally isolated from orga nisms of different taxonomic genera. (1) The term “intergeneric microorganism” includes a mi croorganism which contains a mobile genetic element which was first identified in a microorganism in a genus different from the recipient microorganism. (2) The term “intergeneric microorganism” does not incl ude a microorganism which c ontains introduced genetic material consisting of only well-characterized, non-coding regulatory regi ons from another genus. Introduced genetic material means genetic material that is added to, and remains as a component of, the genome of the recipient.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 Manufacture, import, or process for commercial purposes means: (1) To import, produce, manufacture, or process with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, importer, or processor, and includes, among other things, “manufacture” or “processing” of any amount of a microorganism or microbial mixture: (i) For commercial distribution, including for test marketing. (ii) For use by the manufacturer, including use for product research and developmen t or as an intermediate. (2) The term also applies to substances that are producedcoincidentally during the manufacture, processing, use, or disposal of another microorganism or microbial mixt ure, including byproducts that are separated from that other microorganism or microbial mixture and impurities that remain in that microorganism or microbial mixture. Byproducts and impurities without separate commercial value are nonetheless produced for the purpose of obtaining a commercial advantage, since they are part of the manufacture or processing of a microorganism for commercial purposes. Microbial commercial activity notice or MCAN means a notice for microorganisms submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with subpart D of this part.

Microbial mixture means any combination of microorganisms or mi croorganisms and other chemical substances, if the combination does not occur in nature and is not an article. Microorganism means an organism classified, using the 5-kingdom classification system of Whittacker, in the kingdoms Monera (or Procaryotae), Protista, Fungi, and th e Chlorophyta and the Rhodophyta of the Plantae, and a virus or virus-like particle. Mobile genetic element or MGE means an element of genetic material that has the ability to move genetic material within and between organisms. “Mobile genetic elements” include all plasmids, viruses, transposons, insertion sequences, and other classes of elements with these general properties. New microorganism means a microorganism not included on the Inventory.

NIH Guidelines means the National Institutes of Health (NIH ) “Guidelines for Research Involving Recombinant DNA Molecules” (July 5, 1994). Non-coding regulatory region means a segment of introduced genetic material for which: (1) The regulatory region and any inserted flanking nucleo tides do not code for protein, peptide, or functional ribonucleic acid molecules. (2) The regulatory region solely controls the activity of othe r regions that code for protein or peptide molecules or act as recognition sites for the initiation of nucleic acid or protein synthesis. Small quantities solely for research and development (or “small quantities solely for purposes of scientific experimentation or analysis or research on, or analysis of, such substance or another substance, including such research or analysis for development of a product”) mean s quantities of a microorganism manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that meet the requirements of §725.234.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 Structure means a building or vessel which effectively surr ounds and encloses the microorganism and includes features designed to restrict the microorganism from leaving.

Submission means any MCAN or exemption request submitted to EPA under this part. Technically qualified individual means a person or persons: (1) Who, because of education, training, or experience, or a combination of these factors, is capable of understanding the health and environmental risks associate d with the microorganism which is used under his or her supervision, (2) Who is responsible for enforcing appropriate methods of conducting scien tific experimentation, analysis, or microbiological research to minimize such risks, and (3) Who is responsible for the safety assessments and clearan ces related to the procurement, storage, use, and disposal of the microorganism as may be appropriate or required within the scope of conducting a research and development activity. TSCA Experimental Release Application or TERA means an exemption request fo r a research and development activity, which is not eligible for a full exemption fro m reporting under §725.232, 72 5.234, or 725.238, submitted to EPA in accordance with subpart E of this part.

Well-characterized for introduced genetic material means th at 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 seque nces 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. 

### § 725.8 Coverage of this part. (a) Microorganisms subject to this part. Only microorganisms which are manufactured, imported, or processed for commercial purposes, as defined in §725.3, ar e 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 de finition of “chemical substance” in section 3 of the Act and §720.3(e) 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 subs tances which are part of the microbial mixture. (3) Any microorganism that is manufactured and processed solely for export if the following conditions are met:

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (i) The microorganism is labeled in accordance with sec tion 12(a)(1)(B) of the Act, when the microorganism is distributed in commerce. (ii) The manufacturer and processor can document at th e 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. 

### § 725.12 Identification of microorganisms for Inventory and other listing purposes. To identify and list microorganisms on the Inventory, both taxonomic designations and supplemental information will be used. The supplemental information required in para graph (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 leve l 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 requ est to the submitter, data supporting the taxonomic designation must be provided to EPA. The genetic histor y 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 micr oorganism to be accurately and unambiguously identified. (1) Phenotypic information. Phenotypic information means pertinent tra its that result from the interaction of a microorganism's genotype and the envir onment 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 th e introduced genetic material and the methods used to construct the reported microorganism. Th is also may include information on the vector construct, the cellular location, and the number of copies of the introduced genetic material. 

### § 725.15 Determining applicability when microor ganism identity or use is confidential or uncertain. (a) Consulting EPA. Persons intending to conduct activities involving microorganisms may determine their obligations under this part by consu lting the Inventory or the microorganism s and uses specified in §725.239 or in subpart M of this part. This section establishes procedur es for EPA to assist persons in determining whether the microorganism or the use is listed on the Inventor y, in §725.239 or in subpart M of this part. (1) Confidential identity or use. Insome 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 microorga nism's identity or use has been claimed as CBI, that portion does not appear on the public version of the Inventor y, 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 in formation which masks the confidential busin ess 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 microor ganism or use is on the confidential version.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (2) Uncertain microorganism identity. The current state of scientific knowledge leads to some imprecision in describing a microorganism. As the state of knowledge in creases, 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, 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 fide intent to conduct the activ ity for which reporting is required or for which any exemption may apply. (2) To establish a bona fide intent to manufacture, import, or process a microorganism, the person who intends to manufacture, import, or process the microorganism must submit the following information in writing to the Office of Pollution Prevention and Toxics, Document Control Officer, 7407, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: BIOTECH bona fide submission. (i) Taxonomic designations and supplemen tal information required by §725.12. (ii) A signed statement certifying that the submitter inte nds to manufacture, import, or process the microorganism for commercial purposes. (iii) A description of research and development activ ities conducted with the microorganism to date, demonstration of the submitter's ability to produce or obt ain the microorganism from a foreign manufacturer, and the purpose for which the person will manufacture, import, or process the microorganism. (iv) An indication of whether a related microorganism wa s previously reviewed by EPA to the extent known by the submitter. (v) A specific description of the major intende d application or use of the microorganism. (c) If an importer or processor cannot provide all the in formation required by paragraph (b) of this section, because it is claimed as confidential business information by its foreign manufacturer or supplier, the foreign manufacturer or supplier may supply the information directly to EPA. (d) EPA will review the information submitted by the manuf acturer, importer, or processor under this paragraph to determine whether that person has shown a bona fide intent to manufacture, import, or process the microorganism. If necessary, EPA will comp are this information to the inform ation requested for the confidential microorganism under §725.85(b)(3)(iii). (e) In order for EPA to make a conclusive determin ation of the microorganism's status, the proposed manufacturer, importer, or processor must show a bona fide intent to manufacture, import, or process the microorganism and must provide sufficient informati on to establish identity unambiguously. After sufficient information has been provided, EPA will inform th e manufacturer, importer, or processor whether the microorganism is subject to this part and if so, which sections of this part apply. (f) If the microorganism is found on the confidential version of the Inventory, in §725.239 or in subpart M of this part, EPA will notify the person(s) who originally report ed the microorganism that another person (whose identity will remain confidential, if so requested) has demonstrated a bona fide intent to manufacture, import, or process the microorganism and therefore was told that the microor ganism is on the Inventory, in §725.239, or in subpart M of this part.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (g) A disclosure to a person with a bona fide intent to manufacture, import, or process a particular microorganism that the microorganism is on the Inventory, in §725.239, or in subpart M of this part will not be considered a public disclosure of confidential business information under section 14 of the Act. (h) EPA will answer an inquiry on whether a particular micr oorganism is subject to this part within 30 days after receipt of a complete submission unde r paragraph (b) of this section. 

### § 725.17 Consultation with EPA. Persons may consult with EPA, either in writing or by telephone, about their obligati ons under this part. Written consultation is preferred. Written inquiries should be sen t 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: Bi otechnology Notice Consultation. Persons wishing to consult with EPA by telephone should call (202) 554 –1404; hearing impaired T DD (202) 554–0551 or e-mail: TSCA-Hotline@epamail.epa.gov. 

### Subpart B—Administrative Procedures § 725.20 Scope and purpose. This subpart describes general administrative procedur es applicable to all persons who submit MCANs and exemption requests to EPA under section 5 of the Act for microorganisms. 

### § 725.25 General administrative requirements. (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 in formation as required for the appropriate submission under this part. Except as otherwise provided, each submi ssion 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 pe rmit 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 exem ption requests to EPA under this part, and material related to their reporting obligations under this part, must attachthe 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 subm ission. 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. (c) Where to submit information under this part . MCANs and exemption requests, and any support documents related to these submissions, may only be subm itted in a manner set forth in this paragraph. MCANs and exemption requests, and any related s upport documents, must be generated, co mpleted, 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.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (1) Paper

- based submissions . MCANs and exemption requests, and any support documents related to these submissions, may be submitte d on paper on or before Ap ril 6, 2011. All paper

- based submissions must be generated using e

- PMN reporting software and be completed through the finalization step of the software, and e

PMN software must be used to print the biotechnology notice submission to be sent to EPA. Paper notices must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

– 0001 or submitted via courier to the Environmental Protection Agen cy, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. (2) Submissions on optical disc

— (i) MCANs and exemption requests may be submitted as electronic files on optical disc on or before April 6 , 2012. MCANs and exemption requests submitted as electronic files on optical disc must be generated using e

- PMN reporting software and be completed through the finalization step of the software. Optical discs containing electronic notices must be submitte d by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO ), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. (ii) Persons submitting on optical disc must s till prepare, sign, and submit on paper, the Certification statement in 40 CFR 725.25(b) along with submitter id entification and contact information. (iii) Support documents for MCANs or exemption request s that are submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

– 0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Contro l Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. (3) Submissions via CDX . MCANs and exemption requests, and any related support documents, may be submitted electronically to EPA via CDX. Prior to submission to E PA via CDX, notices must be generated and completed on EPA Form 6300

- 07 using e

- PMN reporting software. (d) General requirements for submission of data. (1) Submissions under this part must include the information described in §725.155, 725.255, 725.355, or 725.455, as appropriate, to the exte nt such information is known to or reasonably ascertainable by the submitter. (2) In accordance with §725.160 or 725.260, as appropriate, th e submission must also include any test data in the submitter's possession or control and descriptions of other data which are known to or reasonably ascertainable by the submitter and which concern the health and environmental effects of the microorganism. (e) Agency or joint submissions. (1) A manufacturer or importer may designate an agent to assist in submitting the MCAN. If so, only the manufacturer or importer, and not the agent, signs the certification on the form. (2) A manufacturer or importer may authorize another pe rson, (e.g., a supplier or a toll manufacturer) to report some of the information required in the MCAN to EPA on its behalf. The manufact urer or importer should indicate in a cover letter accompanying the MCAN whic h information will be supplied by another person and identify that other person as a joint submitter where i ndicated in their MCAN. The other person supplying information (i.e., the joint submitter) may submit the info rmation to EPA either in the MCAN or a Letter of Support, except that if the joint submitter is not incorpor ated, licensed, or doing busin ess in the United States, the joint submitter must submit the information to EPA in a Letter of Support only, rather than the MCAN. The joint submitter must indicate in the MCAN or Letter of Support the identity of the manufacturer or importer. Any person who submits the MCAN or Letter of Support for a joint submission must sign and certify the MCAN or Letter of Support.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (3) If EPA receives a submission which does not include the information required, which the submitter indicates that it has authorized another person to provide, the re view period will not begin until EPA receives all of the required information. (f) Microorganisms subject to a section 4 test rule. (1) Except as provided in paragraph (f)(3) of this section, if a person intends to manufacture or import a new microorganis m which is subject to the notification requirements of this part, and the microorganism is subject to a test ru le promulgated under section 4 of the Act before the notice is submitted, section 5(b)(1) of the Act requires the person to submit the test data required by the testing rule with the notice. The person must submit the data in the form and manner specified in the test rule and in accordance with §725.160. If the person does not submit the test data, the submission is incomplete and EPA will follow the procedures in §725.33. (2) If EPA has granted the submitter an exemption under section 4(c) of the Act from the requirement to conduct tests and submit data, the person may not file a MCAN or TERA until EPA receives the test data. (3) If EPA has granted the submitter an exemption under sec tion 4(c) of the Act and if another person previously has submitted the test data to EPA, the exempted person may either submit the test data or provide the following information as part of the notice: (i) The name, title, and address of the pers on who submitted the test data to EPA. (ii) The date the test data were submitted to EPA. (iii) A citation for the test rule. (iv) A description of the exemption and a reference identifying it. (g) Microorganisms subject to a section 5(b)(4) rule. (1) If a person: (i) Intends to manufacture or import a microorganism which is subject to the notification requirements of this part and which is subject to a rule issuedunder section 5(b)(4) of the Act; and (ii) Is not required by a rule issued under section 4 of th e Act to submit test data for the microorganism before the filing of a submission, the person must submit to EPA data described in paragraph (g)(2) of this section at the time the submission is filed. (2) Data submitted under paragr aph (g)(1) of this section must be data which the person submitting the notice believes show that the manufacture, processing, dist ribution in commerce, use, and disposal of the microorganism, or any combination of such activities, will not present an unreasonable risk of injury to health or the environment. (h) Data that need not be submitted. Specific data requirements are listed in subparts D, E, F, G, and L of this part. The following is a list of data th at need not be submitted under this part: (1) Data previously submitted to EPA. (i) A person need not submit any data previous ly submitted to EPA with no claims of confidentiality if the new submission includes: the office or person to whom the data were submitted; the date of submission; and, if appropriate, a standard literature citation as sp ecified in §725.160(a)(3)(ii). (ii) For data previously submitted to EPA with a claim of confidentiality, the person must resubmit the data with the new submission and any claim of confidentiality, under §725.80.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (2) Efficacy data. This part does not require submission of any data related solely to product efficacy. However, including efficacy data will improve EPA's ability to assess the benefits of the use of the microorganism. This does not exempt a person from submitting any of the data specified in §725.160 or 725.260. (3) Non-U.S. exposure data. This part does not require s ubmission of any data which relates only to exposure of humans or the environment outside the United States. Th is does not exclude nonexposure data such as data on health effects (including epidemiological studies), ecol ogical effects, physical and chemical properties, or environmental fate characteristics. [62 FR 17932, April 11, 1997, as amended at 75 FR 788, Jan. 6, 2010] 

### § 725.27 Submissions. 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 exempti ons (TMEs) are described in §§725.350 an d 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 ne w uses for microorganisms are described at §725.950. 

### § 725.28 Notice that submission is not required. When EPA receives a MCAN or exemption request, EPA w ill review it to determine whether the microorganism is subject to the requirements of this part. If EPA de termines 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. 

### § 725.29 EPA acknowledgement of receipt of submission. (a) EPA will acknowledge receipt of each submission by se nding a letter via CDX or U.S. mail to the submitter that identifies the number assigned to each MCAN or exem ption request and the date on which the review period begins. The review period will begin on the date the MC AN 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. [62 FR 17932, April 11, 1997, as amended at 75 FR 788, Jan. 6, 2010] 

### § 725.32 Errors in the submission. (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:

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (1) Failure to date the submission. (2) Typographical errors that cause data to be misl eading 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 expl ain 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. 

### § 725.33 Incomplete submissions. (a) A submission under this part is not comple te, 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 re quired 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, 725.2 55, 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 confiden tiality claims and has failed to: (i) Submit a second copy of the submission with all co nfidential information deleted for the public file, as required by §725.80(b)(2). (ii) Comply with the substantiation requirements as d escribed 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 th e 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 envi ronment, if EPA has listed the microorganism under section 5(b)(4) of the Act, as required in §725.25(g). (9) For MCANs, the submitter does not remit the fees requi red by §700.45(b)(1) or (b)(2)(vi) of this chapter. (10) The submitter does not include an identifying nu mber and a payment identity number as required by §700.45(e)(3) of this chapter. (11) The submitter does not submit the notice in the manner set forth in §725.25(c).

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (b)(1) If EPA receives an incomplete submission under th is 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 during the review period for any submission that indicates the original submission was incomplete, the Director, or a designee, may declare the submission incomplete within 30 days after EPA obtains the additional info rmation and so notify the submitter. (c) The notification that a submission is incomple te under paragraph (b) of this section will include: (1) A statement of the basis of EPA's determ ination that the submission is incomplete. (2) The requirements for correcting the incomplete submission. (3) Information on procedures under paragraph (d) of this section for filing objections to the determination or requesting modification of the requirements for completing the submission. (d) Within 10 days after receipt of notification by EP A that a submission is incomplete, the submitter may file written objections requesting that EPA accept the submissi on as complete or modify the requirements necessary to complete the submission. (e)(1) EPA will consider the objections filed by the submitte r. The Director, or a designee, will determine whether the submission was complete or incomplete, or whether to modify the requirements for completing the submission. EPA will notify the submitter in writing of EPA's response within 10 days of receiving the objections. (2) If the Director, or a designee, determines, in respon se to the objection, that the submission was complete, the review period will be deemed suspende d on the date EPA declared the submission incomplete, and will resume on the date that the submission is declared complete. The submitter need not correct the submission as EPA originally requested. If EPA can complete its review w ithin the review period beginning on the date of the submission, the Director, or a designee, may inform th e submitter that the running of the review period will resume on the date EPA originally declared it incomplete. (3) If the Director, or a designee, modifies the requireme nts for completing the submission or concurs with EPA's original determination, the review period will begin when EPA receives a complete submission. (f) If EPA discovers at any time that a person submitted mate rially false or misleading statements in information submitted under this part, EPA may find that the submi ssion was incomplete from the date it was submitted, and take any other appropriate action. [62 FR 17932, April 11, 1997, as amended at 75 FR 788, Jan. 6, 2010] 

### § 725.36 New information. (a) During the review period, if a submitter possesses, contro ls, or knows of new information that materially adds to, changes, or otherwise makes significantly more comp lete 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 d escribed in §725.25(c)(1), (c)(2), and (c)(3). (b) The new submission must clearly identify the submitte r, 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.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (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 s ubmission by telephone of the new information. [62 FR 17932, April 11, 1997, as amended at 75 FR 789, Jan. 6, 2010] 

### § 725.40 Notice in th e Federal Register. (a) Filing of Federal Register notice. After EPA receives a MC AN or an exemption request under this part, EPA will issue a notice in the Federal Register including th e 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 submitte r 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, 725.2 60, 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 Federa l Register indicating whether the request has been approved or denied and the reasons for the decision. 

### § 725.50 EPA review. (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 revi ew period under section 5(c) of the Act and §725.56. (b) Exemption requests. The review period starts on the date the Do cument Control Officer receives a complete exemption request, or the date EPA determines the requ est 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. 

### § 725.54 Suspension of the review period. (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 conti nue to run, and EPA will notify the submitter. A submitter may request a suspension at any time during the review pe riod. The suspension must be for a specified period of time.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (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, 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 suspen sion, must be generated, completed, and submitted toEPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain ePMN software. (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, to the submitter's EPA contact for that notice, subject to paragraph (c) of this section. (1) Older notices . Requests for suspension for notices submitted befo re April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

– 0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. (2) Newer notices . For notices submitted on or after April 6, 2010, EPA will accept requests for suspension only if submitted in accordance with this paragraph: (i) Requests for suspension may be submitted on pap er on or before April 6, 2011. All paper

- based requests for suspension must be generated using e

- PMN reporting software and be completed through the finalization step of the software, and e

- PMN software must be used to pr int the request fo r suspension for submission to EPA. Paper requests for suspension must be submitted either via U. S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmen tal Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20 460

– 0001 or submitted via courier to the Envir onmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. (ii) Requests for suspension may be submitted as electronic files on optical disc on or before April 6, 2012. All requests for suspension submitted as electroni c files on optical disc generated using e

- PMN reporting software and be completed through the finali zation step of the software, and e

- PMN software must be used to p rint the request for suspension for submission to EPA. Paper requ ests for suspension must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), O ffice of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Penns ylvania Ave., NW., Washington, DC 20460

– 0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. (iii) 

### Submission of suspension notices. EPA will accept requests for suspension only if submitted in accordance with this paragraph. Requests for suspension , may must be generated, completed, and submitted electronically to EPA ( via CDX ) . Such requests must be generated and completed using e-PMN reporting software. See 40 CFR 720.40(a)(2)( iv ii ) for information on how to obtain e-PMN software. (c) An oral request for suspension may be granted by EPA for a maximum of 15 days only. Requests for longer suspension must only be submitted in the manner set forth in this paragraph. (d) If the submitter has not made a previous oral request , the running of the notice review period is suspended as of the date of receipt of the written paper request, electronic request on optical disc, or CDX submission by EPA. [62 FR 17932, April 11, 1997, as amended at 75 FR 789, Jan. 6, 2010]

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 

### § 725.56 Extension of the review period. (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 revi ew 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 peri od of up to the same length of time as specified for each type of submission in §725.50. If th e 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 a nd is seeking additional information. (2) EPA has received significant additional information during the review period. (3) The submitter has failed to correct a submi ssion 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 th e Act, but EPA is unable to initiate regulatory action within the initial review period. 

### § 725.60 Withdrawal of submission by the submitter. (a) 

### (1) Withdrawal of notice by the submitter. A submitter may withdraw a notice during the notice review period by submitting a statement of withdrawal in a ma nner 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 withdraw al must be generated, completed, and submitted toEPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain ePMN software. A submitter may withdraw a notice during the notice review period by submitting a statement of withdrawal in a manner set forth in this paragraph. Th e withdrawal is effective upon receipt of the written paper request, electronic request on optical disc, or CDX submission by EPA. (1) Older notices . Statements of withdrawal for notices submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Preven tion and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

– 0001 or submitted via courier to the Environmental Protection Ag ency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6 428, Washington, DC 20004. (2) Newer notices . For notices submitted on or after April 6, 2010, EPA will accept statements of withdrawal only if submitted in accord ance with this paragraph:

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (i) Statements of withdrawal may be submitted on paper on or befor e April 6, 2011. All paper

- based statements of withdrawal must be generated using e

- PMN reporting software and be completed through the finalization step of the software, and e

- PMN software must be used to print the statement of withdrawal for submission t o EPA. Paper statements of withdrawal must be submitted eith er via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Envi ronmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

– 0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. (ii) Statements of withdrawal be submitted as electronic files on optical disc o n or before April 6, 2012. All statements of withdrawal submitted as electronic files on optical disc must be generated using e

- PMN reporting software and be completed through the finalization st ep of the software. Optical discs containing electronic state ments of withdrawal must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. (iii) Statements of withdrawal may be submitted electr onically to EPA via CDX. Prior to submission to EPA via CDX, such statements of withdrawal mu st be generated and completed using e

- PMN reporting software. See 40 CFR 720.40(a)(2)(iv) for information on how to obtain e

- PMN software. (b) If a manufacturer, importer, or processor who withdr ew a submission later resubmits a submission for the same microorganism, a ne w review period begins. [62 FR 17932, April 11, 1997, as amended at 75 FR 789, Jan. 6, 2010] 

### § 725.65 Recordkeeping. (a) General provisions. (1) Any person who submits a notice under th is 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 th e 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 reta ined 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 sec tion, specific recordkeeping requirements included in certain subparts must also be followed. (1) Additional recordkeeping requirements for activities conduc ted 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).

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (4) Additional recordkeeping requirements for Tier I exem ptions under subpart G of this part are set forth in §725.424(a)(5). (5) Additional recordkeeping requirements for Tier II exem ptions under subpart G of this part are set forth in §725.450(d). (6) Additional recordkeeping requirements for significant new uses of microorganism s 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. 

### § 725.67 Applications to exempt ne w microorganisms from this part. (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 inform ation to show that any activities affected by the requested exemption will not present an unreasonable ri sk of injury to health or the environment. This information should include data descr ibed in the following paragraphs. (i) The effects of the new microorgani sm 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 busin ess, and technological innovation. (3) Specific requirements. In addition to the requirements of paragr aph (a)(2) of this section, the specific information requirements of the relevant subpart u nder 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 mi croorganism to any other closely related microorganisms which have a potential for adverse e ffects on health or the environment; (C) A history of safe commercial use for the microorganism; (D) Commercial uses indicating that the microorganism products might be subject to TSCA;

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (E) Studies which indicate the potential for the microorg anism to cause adverse effects to health or the environment; and (F) Studies which indicate the survival characteris tics of the microorganism in the environment. (b) Processing of the Letter of Application by EPA —(1) Grant of the Application. If, after consideration of the Letter of Application and any other relevant informat ion available to EPA, the Assistant Administrator for Prevention, Pesticides and Toxic Substances makes a prel iminary determination that the new microorganism will not present an unreasonable risk of injury to health or th e environment, the Assistant Administrator will propose a rule to grant the exemption using the applicab le procedures in part 750 of this chapter. (2) Denial of the application. If the Assistant Administrator decides thatthe preliminary determination described in paragraph (b)(1) of this section cannot be made, the application will be denied by sending the applicant a written statement with the Assistant Administrator's reasons for denial. (c) Processing of the exemption —(1) Unreasonable risk standard. Granting a section 5(h)(4) exemption requires a determination that the activities will not present an unreasona ble risk of injury to health or the environment. (i) An unreasonable risk determination under the Act is anadministrative judgment that requires balancing of the harm to health or the environment that a chemical s ubstance may cause and the magnitude and severity of that harm, against the social and economic effects on society of EPA action to reduce that harm. (ii) A determination of unreasonable risk under sect ion 5(h)(4) of the Act will examine the reasonably ascertainable economic and social consequences of granting or denying the exemption after consideration of the effect on the national economy, small business, technological innovation, the environment, and public health. (2) Grant of the exemption. The exemption will be granted if the Assistant Administrator determines, after consideration of all relevant evidence presented in the ru lemaking proceeding described in paragraph (b)(1) of this section, that the new microorganism will not present an unreas onable risk of injury to health or the environment. (3) Denial of the exemption. The exemption will be denied if the Assistant Administrator determines, after consideration of all relevant evidence presented in the ru lemaking proceeding described in paragraph (b)(1) of this section, that the determination described in paragraph (c)(2) of this section cannot be made. A final decision terminating the rulemaking proceeding will be published in the Federal Register . [62 FR 17932, April 11, 1997, as amended at 75 FR 789, Jan. 6, 2010] 

### § 725.70 Compliance. (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 microorgani sm 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 ha d reason to know was manufactured, processed, or distributed in commerce in violation of section 5 of the Ac t 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).

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (e) Failure or refusal to permit entry or inspection as requi red 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 pe nalties in section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who submit materially misleading or fa lse information in connection with the requirements of any provision of this part may be subject to penalti es 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 viol ation 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). 

### § 725.75 Inspections. 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. 

### Subpart C—Confidentiality and Public Access to Information § 725.80 General provisions for confidentiality claims. (a) A person may assert a claim of confidentiality for any in formation submitted to EPA un der this part. However, (1) Any person who asserts a claim of confidentiality fo r portions of the specific microorganism identity must provide the information as described in §725.85. (2) Any person who asserts a claim of confidentiality for a use of a microorganism must provide the information as described in §725.88. (3) Any person who asserts a claim of confidentiality for in formation contained in a health and safety study of a microorganism must provide the in formation described in §725.92. (b) Any claim of confidentiality must accompany the information when it is submitted to EPA. (1) When a person submits any information under this part, including any attachments, for which claims of confidentiality are made, the claim(s) must be asserted by circling the specific information which is claimed and marking the page on which that information appears w ith an appropriate designation such as “trade secret,” “TSCA CBI,” or “confidential business information.” (2) If any information is claimed confidential, the pers on must submit two copies of the document including the claimed information. (i) One copy of the document must be complete. In thatcopy, the submitter must mark the information which is claimed as confidential in the manner prescrib ed in paragraph (b)(1) of this section. (ii) The second copy must be complete except that all in formation claimed as confidential in the first copy must be deleted. EPA will place the second copy in the public file. (iii) If the submitter does not provide the second copy, the submission is incomplete and the review period does not begin to run until EPA receives the second copy, in accordance with §725.33.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (iv) Any information contained within the copy submi tted under paragraph (b)(2)(ii) of this section which has been in the public file for more than 30 days will be presumed to be in the public domain, notwithstanding any assertion of confidentiality made under this section. (3) A person who submits information to EPA under this part must reassert a claim of confidentiality and substantiate the claim each time th e information is submitted to EPA. (c) Any person asserting a claim of confidentiality under this part must substantiate each claim in accordance with the requirements in §725.94. (d) EPA will disclose information that is subject to a claim of confidentiality asserted under this section only to the extent permitted by the Act, this subpart, and part 2 of this title. (e) If a submitter does not assert a claim of confidentiality for information at the time it is submitted to EPA, EPA may make the information public and place it in the pub lic file without further notice to the submitter. 

### § 725.85 Microorganism identity. (a) Claims applicable to the period prior to commencement of manufacture or import for general commercial use —(1) When to make a claim. (i) A person who submits information to EPAunder this part may assert a claim of confidentiality for portions of the specific microorganism identity at the time of submission of the information. This claim will apply only to the period prior to th e commencement of manufacture or import for general commercial use. (ii) A person who submits informati on to EPA under this part must reassert a claim of confidentiality and substantiate the claim each time the information is s ubmitted to EPA. For example, if a person claims certain information confidential in a TERA submission and wishes the same information to remain confidential in a subsequent TERA or MCAN submission, the person must re assert and resubstantiate the claim in the subsequent submission. (2) Assertion of claim. (i) A submitter may assert a claim of confidentiality only if the submitter believes that public disclosure prior to commencement of manufacture or import for general commercial use of the fact that anyone is initiating research and deve lopment activities pertaining to the specific microorganism or intends to manufacture or import the specific microorganism for ge neral commercial use would reveal confidential business information. Claims must be substantiated inaccordance with the requirements of §725.94(a). (ii) If the submission includes a health and safety studyconcerning the microorganism and if the claim for confidentiality with respect to the specific identity is denied in accordance with §725.92(c), EPA will deny a claim asserted under paragraph (a) of this section. (3) Development of generic name. Any person who asserts a claim of confidentiality for portions of the specific microorganism identity under this para graph must provide one of the following items at the time the submission is filed: (i) The generic name which was accepted by EPA in th e prenotice consultation conduc ted under paragraph (a)(4) of this section. (ii) One generic name that is only as generic as necessary to protect the confidential identity of the particular microorganism. The name should reveal the specific identit y to the maximum extent possible. The generic name will be subject to EPA review and approval.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (4) Determination by EPA. (i) Any person who intends to assert a claim of confidentiality for the specific identity of a new microorganism may seek a determination by EPA of an appropriate generic name for the microorganism before filing a submission. For this purpose, the person should submit to EPA: (A) The specific identity of the microorganism. (B) A proposed generic name(s) which is only as generic as necessary to protect the confidential identity of the new microorganism. The name(s) should reveal the specific identity of the microorganismto the maximum extent possible. (ii) Within 30 days, EPA will inform the submitter either that one of the proposed generic names is adequate or that none is adequate and further consultation is necessary. (5) Use of generic name. If a submitter claims microorganism identity as confidential under paragraph (a) of this section, and if the submitter complies with paragraph (a)(2 ) of this section, EPA will issue for publication in the Federal Register notice described in §725.40 the gene ric name proposed by the submitter or one agreed upon by EPA and the submitter. (b) Claims applicable to the period after commencement of manufacture or import for general commercial use

— (1) Maintaining claim. Any claim of confidentiality under paragraph (a) of this section is applicable only until the microorganism is manufactured or impor ted for general commercial use and b ecomes eligible for inclusion on the Inventory. To maintain the confidential status of the mi croorganism identity when the microorganism is added to the Inventory, a submitter must reassert the confidentia lity claim and substantiate the claim in the notice of commencement of manufacture required under §725.190. (i) A submitter may not claim the microorganism iden tity confidential for the period after commencement of manufacture or import for general commercial use unl ess the submitter claimed the microorganism identity confidential under paragraph (a) of this sec tion in the MCAN submitted for the microorganism. (ii) A submitter may claim the microorganism identity confidential for the period after commencement of manufacture or import for general commercial use if th e submitter did not claim the microorganism identity confidential under paragraph (a) of th is section in any TERA submitted for the microorganism, but subsequently did claim microorganism identity confidential in the MCAN submitted for the microorganism. (2) Assertion of claim. (i) A person who believes that public disclosure of the fact that anyone manufactures or imports the microorganism for general commercial use would reveal confidential business information may assert a claim of confidentiality under paragraph (b) of this section. (ii) If the notice includes a health and safety study co ncerning the new microorganism, and if the claim for confidentiality with respect to the microorganism identit y is denied in accordance with §725.92(c), EPA will deny a claim asserted under paragraph (b) of this section. (3) Requirements for assertion. Any person who asserts a confidentiality cl aim for microorganism identity must: (i) Comply with the requirements of paragraph (a)(3) of this section regarding subm ission of a generic name. (ii) Agree that EPA may disclose to a person with a bona fide intent to manufacture or import the microorganism the fact that the particular microorganism is included on the confidential Inventory for purposes of notification under section 5(a)(1)(A) of the Act. (iii) Have available and agree to furnish to EPA upo n request the taxonomic designations and supplemental information required by §725.12.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (iv) Provide a detailed written substantiation of the clai m, in accordance with the requirements of §725.94(b). (4) Denial of claim. If the submitter does not meet the requirements of paragraph (b) of this section, EPA will deny the claim of confidentiality. (5) Acceptance of claim. (i) EPA will publish a generic na me on the public Inventory if: (A) The submitter asserts a claim of confiden tiality in accordance with this paragraph. (B) No claim for confidentiality of the microorganism iden tity as part of a health and safety study has been denied in accordance with part 2 of this title or §725.92. (ii) Publication of a generic name on the public Inventory does not create a category for purposes of the Inventory. Any person who has a bona fide intent to manufacture or import a microorganism which is described by a generic name on the public Inventory may submit an inquiry to EPA under §725.15(b) to determine whether the particular microorganism is included on the confidential Inventory. (iii) Upon receipt of a request described in §725.15(b ), EPA may require the submitter who originally asserted confidentiality for a microorganism to submit to EPA the in formation listed in paragraph (b)(3)(iii) of this section. (iv) Failure to submit any of the information required unde r paragraph (b)(3)(iii) of this section within 10 calendar days of receipt of a request by EPA under paragraph (b) of this section will constitute a waiver of the original submitter's confidentiality claim. In this event, EPA may place the specific microorganism identity on the public Inventory without further notice to the original submitter. (6) Use of generic name on the public Inventory. If a submitter asserts a claim of confidentiality under paragraph (b) of this section, EPA will examine the generi c microorganism name proposed by the submitter. (i) If EPA determines that the generic name proposed by the submitter is only as generic as necessary to protect the confidential identity of the particular microor ganism, EPA will place that generic name on the public Inventory. (ii) If EPA determines that the generic name proposed by the submitter is more generic than necessary to protect the confidential identity, EPA will propose in writing, fo r review by the submitter, an alternative generic name that will reveal the identity of the microo rganism to the maximum extent possible. (iii) If the generic name proposed by EPA is acceptable to the submitter, EPA will place that generic name on the public Inventory. (iv) If the generic name proposed by EPA is not acceptable to the submitter, the submitter must explain in detail why disclosure of that generic name would reveal conf idential business information and propose another generic name which is only as generic as necessary to protect th e confidential identity of the microorganism. If EPA does not receive a response from the submitter within 30 days after the submitter receives the proposed name, EPA will place EPA's chosen generic name on the public Invent ory. If the submitter does provide the information requested, EPA will review the response. If the submitter' s proposed generic name is acceptable, EPA will publish that generic name on the public Inventory. If the submitte r's proposed generic name is not acceptable, EPA will notify the submitter of EPA's choice of a generic name. Th irty days after this notification, EPA will place the chosen generic name on the public Inventory. 

### § 725.88 Uses of a microorganism.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (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 requi red by paragraph (b) of this section by describing the uses as precisely as possible, without reveali ng 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. 

### § 725.92 Data from health and sa fety studies of microorganisms. (a) Information other than sp ecific microorganism identity. Except as provided in paragraph (b) of this section, EPA will deny any claim of confidentiality with respect to information included in a health and safety study of a microorganism, unless the information would discl ose confidential business information concerning: (1) Processes used in the manufacture or processing of a microorganism. (2) Information which is not in any way related to the e ffects of a microorganism on health or the environment, such as, the name of the submitting company, cost or other financial data, produc t development or marketing plans, and advertising plans, for which the person subm its a claim of confidentiality in accordance with §725.80. (b) Microorganism identity —(1) Claims applicable to the period prior to commencement of manufacture or import for general commercial use. A claim of confidentiality for the period prior to commencement of manufacture or import for general commercial use for the sp ecific identity of a microorganism for which a health and safety study was submitted must be asserted in conjunction with a claim asserted under §725.85(a). The submitter must substantiate each claim in acco rdance with the requirements of §725.94(a). (2) Claims applicable to the period after commencement of manufacture or import for general commercial use. To maintain the confidential status of the specific iden tity of a microorganism for which a health and safety study was submitted after commencement of manufacture or import for general commercial use, the claim must be reasserted and substantiated in conjunction with a clai m under §725.85(b). The submitte r must substantiate each claim in accordance with the requirements of §725.94(b). (c) Denial of confidentiality claim. EPA will deny a claim of confidentiality for microorganism identity under paragraph (b) of this section, unless: (1) The information would disclose processes used in the manufacture or processing of a microorganism. (2) The microorganism identity is not necessar y to interpret a health and safety study. (d) Use of generic names. When EPA discloses a health and safety study containing a microorganism identity, which the submitter has claimed confiden tial, and if the Agency has not denied the claim under paragraph (c) of this section, EPA will identify the microorgani sm by the generic name selected under §725.85.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 

### § 725.94 Substantiation requirements. (a) Claims applicable to the period prior to commencement of manufacture or import for general commercial use —(1) MCAN, TME, Tier I certification, and Tier II exemption request requirements. Any person who submits a MCAN, TME, Tier I certification, or Tier II exemption request should strictly limit confidentiality claims to that information which is confidential and proprietary to the business. (i) If any information in the submission is claimed as confidential business information, the submitter must substantiate each claim by submitting written answers to th e questions in paragraphs (c), (d), and (e) of this section at the time the person submits the information. (ii) If the submitter does not provide written substantiation as required in paragraph (a)(1 )(i) of this section, the submission will be considered incomplete and the re view period will not begin in accordance with §725.33. (2) TERA requirements. Any person who submits a TERA, should stric tly limit confidentiality claims to that information which is confidential and proprietary to th e business. If any information in such a submission is claimed as confidential business informa tion, the submitter must have availa ble for each of those claims, and agree to furnish to EPA upon request, written answers to th e questions in paragraphs (d ) and (e) of this section. (b) Claims applicable to the period after commencement of manufacture or import for general commercial use. (1) If a submitter claimed portions of the microorganism identity confidential in the MCAN and wants the identity to be listed on the confidential Inventory, the claim must be reasserted and substantiated at the time the Notice of Commencement (NOC) is submitted under §725.190. Othe rwise, EPA will list the specific microorganism identity on the public Inventory. (2) The submitter must substantiate the claim for confiden tiality of the microorganism identity by answering all of the questions in paragraphs (c), (d), and (e) in this section. In addition, th e following questions must be answered: (i) What harmful effects to the company's or instituti on's competitive position, if any, would result if EPA publishes on the Inventory the identity of the microorgani sm? How could a competitor use such information given the fact that the identity of the microorganism otherwise would appear on the TSCA Inventory with no link between the microorganism and the company or institu tion? How substantial would the harmful effects of disclosure be? What is the causal relationship be tween the disclosure and the harmful effects? (ii) Has the identity of the microorganism been kept conf idential to the extent that competitors do not know it is being manufactured or imported for general commercial use by anyone? (c) General questions. The following questions must be answered in detail for each confidentiality claim: (1) For what period of time is a claim of confidentiality being asserted? If the claim is to extend until a certain event or point in time, indicate that event or time period . Explain why the information should remain confidential until such point. (2) Briefly describe any physical or procedural restricti ons within the company or in stitution relating to the use and storage of the information claimed as confidential. What other steps, if any, apply to use or further disclosure of the information? (3) Has the information claimed as confidential been di sclosed to individuals outside of the company or institution? Will it be disclosed to such persons in the future? If so, what r estrictions, if any, apply to use or further disclosure of the information?

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (4) Does the information claimed as confidential appear, or is it referred to, in any of the following questions? If the answer is yes to any of these questions, indicate wh ere the information appears and explain why it should nonetheless be treated as confidential. (i) Advertising or promotional materials for th e microorganism or the resulting end product? (ii) Material safety data sheets or other similar mate rials for the microorganism or the resulting end product? (iii) Professional or trade publications? (iv) Any other media available to the public or to competitors? (v) Patents? (vi) Local, State, or Federal agency public files? (5) Has EPA, another Federal agency, a Federal court, or a State made any confidentia lity determination regarding the information claimed as confidential? If so, provide copies of such determinations. (6) For each type of information claimed confidential, describe the harm to the company's or institution's competitive position that would result if this information were disclosed. Why would th is harm be substantial? How could a competitor use such information? What is the causal connection between the disclosure and harm? (7) If EPA disclosed to the public th e information claimed as confidential, how difficult would it be for the competitor to enter the market for the resulting product? Consider such constraints as capital and marketing cost, specialized technical expertise, or unusual processes. (d) Microorganism identity and production method. If confidentiality claims are asserted for the identity of the microorganism or information on how the microorganism is produced, the following questions must be answered: (1) Has the microorganism or method of production been patented in the U.S. or elsewhere? If so, why is confidentiality necessary? (2) Does the microorganism leave the site of production or t esting in a form which is accessible to the public or to competitors? What is the cost to a competitor, in time and money, to develop appr opriate use conditions? What factors facilitate or impede product analysis? (3) For each additional type of information claimed as confidential, explain what harm would result from disclosure of each type of information if the identity of the microorganism were to remain confidential. (e) Health and safety studies of microorganisms. If confidentiality claims are asserted for information in a health or safety study of a microorganism, the following questions must be answered: (1) Would the disclosure of the information claimed c onfidential reveal: confidential process information, or information unrelated to the effects of the microorgani sm on health and the environment. Describe the causal connection between the disclosure and harm. (2) Does the company or institution ass ert that disclosure of the microorganism identity is not necessary to interpret any health and safety studies which have b een submitted? If so, explain how a less specific identity would be sufficient to interpret the studies.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 

### § 725.95 Public file. All information submitted, including any health and safety study of a microor ganism and other supporting documentation, will become part of the public file for that submission, unless such materials are claimed confidential. In addition, EPA may add materials to the public file, unless such materials are claimed confidential. Any of the nonconfidential material desc ribed in this subpart will be availa ble for public inspection in the TSCA Public Docket Office, Rm. NE-B607, 401 M St., SW., Washington, DC, between the hours of noon to 4 p.m., Monday through Friday, excluding legal holidays. 

### Subpart D—Microbial Commercial Activi ties Notification Requirements § 725.100 Scope and purpose. (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 a nd 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 r esearch 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 submis sion are described in §725.105. (c) Exclusions and exemptions specific to MCAN submissions are described in §725.110. (d) Submission requirements applicable specifi cally 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. 

### § 725.105 Persons who must report. (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 produ ce or process a new microorganism and the manufacturer produces or processes the microorganism exclusively for thatperson, 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 re port, EPA should be contacted to determine who must submit the MCAN. (3) Only manufacturers that are incorporated, licen sed, or doing business in the United States may submit a MCAN.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (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 microor ganism. Exclusions are described in §725.110. (2) When several persons are involved in an import tr ansaction, the MCAN must be submitted by the principal importer. If no one person fits the prin cipal 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 th is subpart D apply to each person who submits a MCAN for a new microorganism wh ich such person intends to import for a commercial purpose. In addition, each importer must comp ly 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 truthf ulness of all information which it submits. (c) Manufacturers, importers, or processors of microorganisms for a significant new use. MCAN submission is required for any person who intends to manufacture, im port, or process for commercial purposes a microorganism identified as having one or more significant new uses in subpart M of this part, and who intends either to engage in a designated significant new use of the microorganism or intends to distribute it in commerce. Persons excluded from reporting on significant new uses of micr oorganisms and additional pr ocedures for reporting are described in subpart L of this part. 

### § 725.110 Persons not subject to this subpart. Persons are not subject to the requirements of this subpart for the following activities: (a) Manufacturing, importing, or processing solely for r esearch 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. 

### § 725.150 Procedural requirements for this subpart. General requirements for all MCANs under this part are contained in subparts A through C of this part. In addition, the following requirements appl y to MCANs submitted under this subpart: (a) When to submit a MCAN. A MCAN must be submitted at least 90 cal endar 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 applicab le 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 s ubpart must provide the information and test data described in §§725.155 and 725.160.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (d) Recordkeeping. Each person who submits a MCAN under this s ubpart must comply with the recordkeeping requirements of §725.65. 

### § 725.155 Information to be included in the MCAN. (a) Each person who is required by this part to s ubmit a MCAN must include the information specified in paragraphs (c) through (h) of this secti on, to the extent it is known to or reasonably ascertainable by that person. However, no person is required to include information whic h 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, in cluding information on its effects on humans, animals, plants, and other microorganisms, and in the environmen t. The information to be submitted under this subpart includes the information listed in paragraphs (c) thro ugh (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 (incl uding 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 identifie d 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 subs tantiating taxonomy, provided EPA, upon request to the submitter, may have access to the data supporting the taxonom ic 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. (2) Genetic construction of the new microorganism. (i) Data substantiating the taxonomy of the donor organism(s). In lieu of data, EPA will accept a letter fr om a culture collection substantiating taxonomy, provided EPA, upon request to the submitter, may have access to the data supporting th e taxonomic designation. (ii) Description of the traits for which the new microorg anism has been selected or developed and other traits known to have been added or modified. (iii) A detailed description of the gene tic construction of the new microorganism, including the technique used to modify the microorganism (e.g., fusion of cells, inject ion of DNA, electroporation or chemical poration, or methods used for induced mutation and selection). The d escription should include, for example, a description of the introduced genetic material, including any regulatory sequences and structural genes and the products of those genes; how the introduced genetic material is expected to affect behavior of the recipient; expression, alteration, and stability of the introduced genetic material; met hods for vector constructi on and introduction; and a description of the regulatory and structural genes that are components of the introduced genetic material, including genetic maps of the introduced sequences.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (3) Phenotypic and ecological characteristics. (i) Habitat, geographical distribution, and source of the recipient microorganism. (ii) Survival and dissemination under relevant environm ental conditions including a description of methods for detecting the new or recipient microorganism(s) in the environment and the sensitivity limit of detection for these techniques. (iii) A description of anticipated biological interactions with and effects on target or ganisms and other organisms such as competitors, prey, hosts, symbionts, parasites, and pathogens; a description of host range; a description of pathogenicity, infectivity, toxicity, virulence, or action as a vector of pathogens; and capacity for genetic transfer under laboratory and relevant environmental conditions. (iv) A description of anticipated involvement in biogeoc hemical or biological cycling processes, involvement in rate limiting steps in mineral or nutrient cycling, or involvement in inorganic compounds cycling (such as possible sequestration or transformation of heavy metals). (e) Byproducts. A description of the byproducts resulting from the manufacture, processing, use, and disposal of the new microorganism. (f) Total production volume. The estimated maximum amount of the new microorganism intended to be manufactured or imported during the first year of production and the estimated maximum amount to be manufactured or imported during any consecutive 12–month period during the first 3 years of production. This estimate may be by weight or volume and should include an estimation of viability (i.e., viable cells per unit volume or colony forming units per unit dry weight). (g) Use information. A description of intended categories of use by function and application, the estimated percent of production volume devoted to each category of u se, and the percent of the new microorganism in the formulation for each commercial or consumer use. (h) Worker exposure and environmental release. (1) For sites controlled by the submitter: (i) The identity of sites where the new microorganism will be manufactured, processed, or used. For purposes of this section, the site for a person who imports a new micr oorganism is the site of the operating unit within the person's organization which is directlyresponsible for importing the new microorganism and which controls the import transaction. The import site may in some cases be the organization's headquarters office in the United States. (ii) A process description of each manufacture, processi ng, and use operation, which includes a diagram of the major unit operations and conversions, the identity and en try point of all feedstocks, and the identity of any possible points of release of the new microorganism from the process, including a description of all controls, including engineering controls, u sed to prevent such releases. (iii) Worker exposure information, including worker ac tivities, physical form of process streams which contain the new microorganism to which workers may be exposed, the number of workers, and the duration of activities. (iv) Information on release of the new microorganism to the environment, including the quantity and media of release and type of control technology used. (v) A narrative description of the intended transport of th e new microorganism, including the means of transport, containment methods to be used during transport, and emergency containment procedures to be followed in case of accidental release.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (vi) Procedures for disposal of any articles, waste, clothing, or other equipment involved in the activity, including procedures for inactivation of the new microorganism, cont ainment, disinfection, and disposal of contaminated items. (2) For sites not controlled by the submitter, a descripti on of each type of processing and use operation involving the new microorganism, including identification of the estim ated number of processing or use sites, situations in which worker exposure to and/or environmental releas e of the new microorganism will occur, the number of workers exposed and the duration of exposure; proce dures for transport of the new microorganism and for disposal, including procedures for inactivation of th e new microorganism; and control measures which limit worker exposure and environmental release. 

### § 725.160 Submission of health and environmental effects data. (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 l iterature, the submitter must provide a full report. A full report includes the experimental methods and material s, 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, th e submitter need only provide a standard literature citation. A standard literature citation includes author, title, peri odical name, date of public ation, 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 study, report, or test, as specified in paragraph (a)(3)(i) of this section, to the address listed in §725.25(c) within 10 days of receiving it, but no later than 5 days before the end of the review period. If the test or experiment is completed during the last 5 days of the review period, the submi tter must immediately inform its EPA contact for that submission by telephone.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (5) For test data in the submitter's po ssession or control which are not listed inparagraph (a)(2) of this section, a person is not required to submit a complete report. Th e person must submit a summary of the data. If EPA so requests, the person must submit a full report within 10 days of the request, but no later than 5 days before the end of the review period. (6) All test data described under paragraph (a) of this s ection are subject to these requirements, regardless of their age, quality, or results. (b) Other data concerning the health and environmental eff ects of the new microorganism that are known to or reasonably ascertainable by the submitter. (1) Except as provided in §725.25(h), and in addition to the information required by §725.155(c)(3), any person who submits a MCAN must describe the following data, including any data from a health and safety study of a microor ganism, if the data are related to effects on health or the environment of any manufacture, processing, distribution in commerce, use, or disposal of the microorganism, of any microbial mixture or article containing the new mi croorganism, or of any combination of such activities: (i) Any data, other than test data, inthe submitter's possession or control. (ii) Any data, including test data, which are not in the submitter's possession or control, but which are known to or reasonably ascertainable by the submitter. For the purpo ses of this section, data are known to or reasonably ascertainable by the submitter if the data are known to an y of its employees or other agents who are associated with the research and development, test marketi ng, or commercial marketing of the microorganism. (2) Data that must be described include data concerni ng the new microorganism in a pure culture or formulated form as used or as intended to be used in one of th e activities listed in paragraph (b)(1) of this section. (3) The description of data reported under pa ragraph (b) of this section must include: (i) If the data appear in the open scientific literature, a st andard literature citation, wh ich includes the author, title, periodical name, date of publication, volume, and pages. (ii) If the data are not available in the open scientific l iterature, a description of the type of data and summary of the results, if available, and the names and addresses of persons the submitter believes may have possession or control of the data. (4) All data described in paragraph (b ) of this section are subject to these requirements, regardless of their age, quality, or results; and regardless of whether they are complete at the time the MCAN is submitted. 

### § 725.170 EPA review of the MCAN. General procedures for review of a ll submissions under this part are c ontained 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 sp ecified in section 5(a) of the Act runs for 90 days from the date the Document Control Officer for the Offi ce of Pollution Prevention and Toxics receives a complete MCAN, or the date EPA determines the MCAN is comple te under §725.33, unless the Agency extends the period under section 5(c) of the Act and §725.56. (b) Notice of expiration of MCAN review period. (1) EPA will notify the submitter that the MCAN review period has expired or that EPA has completed its review of the MCAN. Expiration of the review period does not constitute EPA approval or certification of the new micr oorganism, and does not mean that EPA may not take regulatory action against the microorganism in the future.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (2) After expiration of the MCAN review period, in th e absence of regulatory action by EPA under section 5(e), 5(f), or 6(a) of the Act, the submitter may manufacture or import the microorganism even if the submitter has not received notice of expiration. (3) Early notification that EPA has completed its re view does not permit commencement of manufacture or import prior to the expiration of the 90–day MCAN review period. (c) No person submitting a MCAN in response to the require ments of this subpart may manufacture, import, or process a microorganism subject to this subpart until the review period, including all extensions and suspensions, has expired. 

### § 725.190 Notice of commencemen t of manufacture or import. (a) Applicability. Any person who commences the manufacture or im port of a new microorganism for nonexempt, commercial purposes for which that person previously subm itted 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, commercia l 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 manuf acture 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 manufactu re or import commences. If the person claimed microorganism identity confidential in the MCAN, and wants the identity to be listed on the confidential Inventory, the claim must be reasserted and resubsta ntiated in accordance with §725.85(b). Otherwise, EPA will list the specific microorganism identity on the public Inventory. (d) Where How to submit . All notices of commencement must be generated, completed, and submitted to EPA in a manner set forth in this paragraph. (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software. (1) Older notices . Notices of commencement for a MCAN submitte d before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

– 0001 or submi tted via courier to the Environmental Protection Agen cy, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. (2) Newer notices . For MCANs submitted on or after April 6, 2010, EPA will accept notices of commencement only if submitted in accord ance with this paragraph: (i) Notices of commencement may be submitted on pa per on or before April 6, 2011. All paper

- based notices of commencement must be generated using e

- PMN reporting software and be c ompleted through the finalization step of the software, and e

- PMN software must be used to print the statement of withdrawal for submission to EPA. Paper notices of commencement must be submitted e ither via U.S. mail to th e Document Control Office (DCO) (7 407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

– 0001 or submitted via courier to the Environmental Protection

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1 201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. (ii) Notices of commencement may be submitted as electroni c files on optical disc on or before April 6, 2012. All notices of commencement submitted as electronic files on optical disc must be gene rated using e

- PMN reporting software and be completed through the finalization st ep of the software. Optical discs containing electronic notices of commencement must be submitted by courie r to the Environmental Protection Agency, OPPT Document Control Offi ce (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. (iii) Notices of commencement may be submitted electronica lly to EPA via CDX on or after April 6, 2010. After April 6, 2012 all notices of commencement must be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, such notices of commenc ement must be generate d and completed using e

- PMN reporting software. See 40 CFR 720.40(a)(2)(iv) for information on how to obtain e

- PMN software. [62 FR 17932, April 11, 1997, as amended at 75 FR 789, Jan. 6, 2010] 

### Subpart E—Exemptions for Research and Development Activities § 725.200 Scope and purpose. (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 §§7 25.270 and 725.288. (g) Subparts A through C of this part apply to any submission under this subpart. 

### § 725.205 Persons who may report under this subpart. (a) Commercial research and development activities i nvolving 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 mean s 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. Indi cations 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 contr acts directly with a university or researcher; or

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (ii) Situations in which a commercial entity gives a co nditional 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 funde d 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 adva ntage may include, but are not limited to: (i) The research is directed toward developing a comme rcially viable improvement of a product already on the market; or (ii) The researcher has sought or is seeking commercia l funding for the purpose of developing a commercial application; or (iii) The researcher or university has sought or is seeki ng 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 fo r the research and has directed the research toward developi ng that application. (c) Certain research and development activities involving mi croorganisms subject to jurisdiction under the Act are exempt from reporting under this part . A person conducting research and de velopment activities which meet the conditions for the exemptions describ ed in §§725.232, 725. 234, or 725.238 is exempt from TERA reporting under this subpart. (d) A microorganism is not exempt from reporting unde r subpart D of this part if any amount of the microorganism, including as part of a mixture, is processed , distributed in commerce, or used, for any commercial purpose other than research and development. (e) Quantities of the inactivated microorganism, or mixtur es or articles containing the inactivated microorganism, remaining after completion of research and development activities may be disposed of as a waste in accordance with applicable Federal, State, and local regulations. (f) A person who manufactures, imports, or processes a micr oorganism solely for research and development is not required to comply with the re quirements of this section if: (1) The person is manufacturing a microbia l pesticide identified in §172.45(c), or (2) The person is manufacturing a microbial pesticide for wh ich an Experimental Use Pe rmit is required, pursuant to §172.3; or (3) The person is manufacturing a microbial pesticide for wh ich a notification or an Experimental Use Permit is not required to be submitted. 

### § 725.232 Activities subject to the jurisdicti on of other Federal programs or agencies. This part does not apply to any r esearch and development activity that meets all of the following conditions. (a) The microorganism is manufactured, imported, or pr ocessed solely for research and development activities.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (b) There is no intentional testing of a microorganism outsi de of a structure, as struct ure 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 condu cted in accordance with the relevant portions of the NIH Guidelines, or (2) A Federal agency or program otherwise imposes the le gally binding requirement that the research is to be conducted in accordance with relevant portions of the NIH Guidelines. 

### § 725.234 Activities conducte d inside a structure. 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 pr ocessed 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 mu st 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 outsi de of a structure, as struct ure is defined in §725.3. (d) Containment and/or inactivation controls. (1) Selecti on 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 cont ainment and/or inactivation controls shall be approved and certified by an authorized official (other than the TQ I) 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 cond ucted, shall be submitted to EPA upo n 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 th is section, changes to the containment/inactivation controls select ed under paragraph (d)(1) of this sec tion must be made upon EPA order. Failure to comply with EPA's order sh all result in automatic loss of eligibilit y for an exemption under this section. (e) The manufacturer, importer, or processor notifies all persons in its employ or to whom it directly distributes the microorganism, who are engaged in experimentation, research, or analysis on the microorganism, including the manufacture, processing, use, transport, storage, and disposal of the microorganism associated with research and development activities, of any risk to health, identif ied under §725.235(a), which may be associated with the microorganism. The notification must be made in accordance with §725.235(b). 

### § 725.235 Conditions of exemption for acti vities conducted inside a structure.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (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 manuf acturer, 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 a ny 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 EPArule 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 labe ling system, conspicuous placement of notices in areas where exposure may occur, written notification to eachperson potentially exposed, or any other method of notification which adequately informs persons of healthrisks which the manufacturer, importer, or processor has reason to believe may be associated with the microorgani sm, as determined under para graph (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 manufacturer, importer, or processor must in written form: (i) Notify those persons that the microorganism is to be used only for research and development purposes and the requirements of §725.234 are to be met. (ii) Provide the notice of health risks speci fied in paragraph (b)(1) of this section. (3) The adequacy of any notification under this section is the responsibility of the manufacturer, importer, or processor. (c) Recordkeeping. (1) For research conducted in accordance w ith the NIH Guidelines, a person who manufactures, imports, or processes a microorganism under this section must retain the following records: (i) Documentation that the NIH Guidelines have b een adhered to. Such documentation shall include: (A) For experiments subject to Institutional Biosafet y Committee review, or notification simultaneous with initiation of the experiment, the information submitted for re view or notification, along with standard laboratory records, shall satisfy the recordkeeping requirements specified in §725.234(d)(3). (B) For experiments exempt from Institutional Biosafety Committee review or notification simultaneous with initiation of the experiment, documentation of the exemption, along with standard laboratory records, shall satisfy the recordkeeping requirement specified in §725.234(d)(3).

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (ii) Documentation of how the following requi rements are satisfied under the NIH Guidelines: (A) Copies or citations to information reviewed and evaluated to determine the need to make any notification of risk. (B) Documentation of the nature and method of notifica tion of risk, including copies of any labels or written notices used. (C) The names and addresses of any persons other than the manufacturer, importer, or processor to whom the substance is distributed, the identity of the microorganism , the amount distributed, and copies of the notifications required. (2) For all other research conducted in accordance wi th §725.234, a person who manufacturers, imports, or processes a microorganism under this section, must maintain the following records: (i) Records describing selection and use of containment and/or inactivation controls required by §725.234(d)(3) and certification by an authorized official re quired by §725.234(d)(2) for each microorganism. (ii) Copies or citations to information reviewed and eval uated under paragraph (a) of th is section to determine the need to make any notification of risk. (iii) Documentation of the nature and method of notifi cation under paragraph (b)(1) of this section, including copies of any labels or written notices used. (iv) The names and addresses of any persons other than the manufacturer, importer, or processor to whom the substance is distributed, the identity of the microorganism , the amount distributed, and copies of the notifications required under paragraph (b)(2) of this section. 

### § 725.238 Activities conducted outside a structure. (a) Exemption. (1) Research and development activities involving inte ntional testing in the environment of certain microorganisms listed in §725.239 may be c onducted 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 micr oorganism listed in §725.2 39 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 sec tion, 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 exemp tion specified for the microorganism in §725.239. (ii) If state and/or local authorities have been no tified of the activity, evidence of notification.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (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 require ments for the microorganism listed in §725.239. 

### § 725.239 Use of specific microorganisms in activities conducted outside a structure. (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 inter est, 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 st reptomycin 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 expr ession 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 sequen ces 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 appr opriate methods to limit the dissemination of modified Bradyrhizobium japonicum. (b) Rhizobium meliloti. To qualify for an exemption under this secti on, 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 following components: (A) The structural gene(s) of inter est, which have the following limitations:

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 ( 1 ) For structural genes encoding marker sequences, the gene is limited to the aadH gene, which confers resistance to the antibiotics st reptomycin 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 expr ession 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 sequen ces 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 appr opriate methods to limit the dissemination of modified Rhizobium meliloti. 

### § 725.250 Procedural requi rements for the TERA. General requirements for all submissions under this part are contained in s ubparts A through C of this part. In addition, the following requirements appl y to TERAs submitted under this subpart: (a) When to submit the TERA. Each person who is eligib le to submit a TERA under this subpart must submit the TERA at least 60 calendar days before the person inte nds to initiate the proposed research and development activity. (b) Contents of the TERA. Each person who submits a TER A under this subpart must provide the information and test data described in §§725.255 and 725.260. In addition, the submitter mu st supply sufficient information to enable EPA to evaluate the effects of a ll activities for which approval is requested. (c) A person may submit a TERA for one or more microor ganisms and one or more research and development activities, including a research program. (d) EPA will either approve the TERA, with or withou t 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.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (2) Summaries of all data, conclusi ons, and reports resulting from the c onduct of the research and development activity under the TERA must be submitted to the EPA a ddress identified in §725.25(c) within 1 year of the termination of the activity. 

### § 725.255 Information to be included in the TERA. (a) To review a TERA, EPA must have sufficient inform ation to permit a reasoned evaluation of the health and environmental effects of the planned test in the envi ronment. The person seeking EPA approval must submit all information known to or reasonably ascertainable by th e submitter on the microorganism(s) and the research and development activity, including information not listed in para graphs (c), (d), and (e) of this section that the person believes will be useful for EPA's risk assessment. The TER A must be in writing and must include at least the information described in the following paragraphs. (b) When specific information is not submitted, an explan ation of why such information is not available or not applicable must be included. (c) Persons applying for a TERA, must include th e 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 testi ng the microorganisms in the environment. (ii) Number of microorganisms relea sed (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 activit y, and description of site characteristics that would influence dispersal or confinement. (iv) Target organisms (if the microorganism(s) to be te sted has an intended target), including identification of each target organism and anticipated mechanism and result of interaction. (v) Planned start date and duration of each activity. (vi) If State and/or local authorities have been no tified of the activity, evidence of notification. (2) Information on monitoring, confinement, miti gation, and emergency termination procedures. (i) Confinement procedures for the activity, access and security measures, and procedures for routine te rmination of the activity. (ii) Mitigation and emergency procedures. (iii) Measures to detect and control potential adverse effects. (iv) Name of principal investigator and chief of site personnel responsible for emergency procedures.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (v) Personal protective equipment, engineering controls, and procedures to be followed to minimize dispersion of the microorganism(s) by people, machinery, or equipment. (vi) Procedures for disposal of any articles, waste, cl othing, machinery, or other equipment involved in the experimental release, including methods for inactivation of the microorganism(s), containment, disinfection, and disposal of contaminated items. 

### § 725.260 Submission of health and environmental effects data. Each TERA must contain all available data concerning actua l or potential effects on health or the environment of the new microorganism that are in the possession or contro l 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 th e manner described in §725.160(a)(3) and (b)(3). 

### § 725.270 EPA review of the TERA. General procedures for review of a ll submissions under this part are c ontained in §§725.28 through 725.60. In addition, the following procedures apply to EPA revi ew of applications subm itted 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 subm itter 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 th e 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 a pproval 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 fo r 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 c onduct the research and development activity only as described in the TERA and in accordance with any require ments and conditions prescribed by EPA in its approval of the TERA. (3) Any person who fails to conduct the research and development activity as described in the TERA and in accordance with any requirements and conditions prescrib ed by EPA in its approval of the TERA under this

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 section, shall be in violation of sections 5 and 15 of th e Act and be subject to civil and criminal penalties under section 16 of the Act. 

### § 725.288 Revocation or modi fication of TERA approval. (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 determin ation 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 writi ng 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 unreas onable risk of injury to h ealth or the environment, it will notify the submitter in writing. To make this fi nding, EPA may prescribe additional conditions which must be followed by the submitter. (ii) If EPA determines that it can no longer conclude th at 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 term inate the research and developm ent 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 th is 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 safeguard s 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 in structions contained in the notice. The submitter may then submit additional information or arguments concerning the matters ra ised by EPA and whether EPA should modify or revoke the approval of the TERA inaccordance with paragraph (a)(2) of this section. (4) EPA will consider the information and arguments in accordance with paragraph (a)(3) of this section. (5) Following consideration of the information and argum ents under paragraph (a)(3) of this section, if EPA notifies the submitter that the R&D activity must be suspended or terminted, the submitter may resume the activity only upon written notice from EPA that EPA has approved resumption of the activity. In approving resumption of an activity, EPA may prescribe additional conditions which must be followed by the submitter. (c) Modifications. If, after approval of a TERA under this subpart, the submitter concludes that it is necessary to alter the conduct of the research and development activit y in a manner which would result in the activity being different from that described in the TERA agreement and any conditions EPA prescribed in its approval, the submitter must inform the EPA contact for the TERA and may not modify the activity without the approval of EPA. 

### Subpart F—Exemptions for Test Marketing

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 

### § 725.300 Scope and purpose. (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, pe rsons 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 appl y to any submission under this subpart. 

### § 725.305 Persons who may apply under this subpart. A person identified in this section may apply for a test ma rketing 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. 

### § 725.350 Procedural requirements for this subpart. General requirements for all submissions under this part are contained in s ubparts 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 appl y for a TME under this subpart must submit the application at least 45 calendar days before th e person intends to commence the test marketing activity. (c) Recordkeeping. Each person who is granted a TME must complywith the recordkeeping requirements of §725.65. In addition, any person w ho obtains a TME must retain docum entation 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. 

### § 725.355 Information to be incl uded in the TME application. (a) To review a TME application, EPA must have suffi cient 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 para graphs (c), (d), and (e) of this section that the person believes will demonstrate that the microorganism will not pr esent an unreasonable risk of injury to health or the

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 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 explan ation of why such information is not available or not applicable must be included. (c) Persons applying for a TME must submit the submitte r 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 conditi ons of the proposed test marketing activity. (e) Persons applying for a TME must also submit the fo llowing 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 dura tion and route of such exposures. (iv) A description of the test marketing activity, incl uding its duration and how it can be distinguished from fullscale commercial production and resear ch and development activities. (2) Health and environmental effects data. All existing data regarding health and environmental effects of the microorganism must be reporte d in accordance with §725.160. 

### § 725.370 EPA review of the TME application. General procedures for review of a ll submissions under this part are c ontained in §§725.28 through 725.60. In addition, the following procedures apply to EPA reviewof 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 r estrictions necessary to ensure that the microorganism will not present an unreasonable risk of injury to healthand the environment as a result of test marketing. 

### Subpart G—General Exemptions for New Microorganisms § 725.400 Scope and purpose. (a) This subpart describes exemptions from reporting under s ubpart D of this part, and from review under this part altogether, for manufacturing and importing of certa in new microorganisms for commercial purposes. (b) Recipient microorganisms eligible for the tiered exem ption from review under this part are listed in §725.420. (c) Criteria for the introduced genetic material containe d in the new microorganisms are described in §725.421.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (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, pers ons using recipient microorganisms eligible for the tiered exemption may submit a Tier II exemption request. The limit ed 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. § 725.420 Recipient microorganisms. The following recipient microorganisms are elig ible 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. 

### § 725.421 Introduced genetic material. 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 expr ession of solely the gene(s) of interest. (3) Associated nucleotide sequences needed to move gene tic material, including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (4) The nucleotide sequences n eeded for vector transfer. (5) The nucleotide sequences need ed for vector maintenance. (b) Well-characterized. For introduced genetic material, well-characte rized 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 seque nces 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 materi al 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 desc ribed in this paragraph (d). (i) For the purposes of this section, a functional portion of a toxin-encoding sequen ce 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 target cells. An example of a sequence which directly contributes to toxic effects in humans is one which encodes the portion of diphtheria toxin, listed in paragraph (d)(2) of this section, capable of interacting with elongation factor 2, leading to inhibition of protein synthesis in target respiratory, heart, kidney, and nerv e tissues. Indirectly contributes to toxic effects in humans means a sequence whose encoded polypeptide is not direc tly toxic to target cells, yet still adversely affects humans. An example of a sequence which indirectly contri butes to toxic effects is the sequence which encodes the portion of the botulinum toxin, listed in paragraph (d)(3) of this section, capable of blocking the release of acetylcholine from gangliosides. Botulinum toxin affe cts neuromuscular junctions by its blockage of acetylcholine release, leading to irreversible relaxation of muscles and respiratory arrest. (B) It binds a toxin or toxin precursor to target human cells. (C) It facilitates intracellular transport of a toxin in target human cells. (ii) While these toxins are listed (with synonyms in parentheses) in paragraphs (d)(2) through (d)(7) of this section according to the source organism, it is use of the nucleo tide sequences that encode the toxins that is being restricted and not the use of the source organisms. The source organisms are listed to provide specificity in identification of sequences whose use is restricted. Alt hough similar or identical sequences may be isolated from organisms other than those listed below in paragraphs (d )(2) through (d)(7) of this section, these comparable toxin sequences, regardless of the organism from which they are derived, must not be included in the introduced genetic material. (2) Sequences for protein synthesis inhibitor.

Sequence Source Toxin Name Corynebacterium diphtheriae & C. ulcerans Diphtheria toxin

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 Pseudomonas aeruginosa Exotoxin A Shigella dysenteriae Shigella toxin (Shiga toxin, Shigella dysenteriae type I toxin, Vero cell toxin) Abrus precatorius, seeds Abrin Ricinus communis, seeds Ricin (3) Sequences for neurotoxins

. Sequence Source Toxin Name Clostridium botulinum Neurotoxins A, B, C1, D, E, F, G (Botulinum toxins, botulinal toxins) Clostridium tetani Tetanus toxin (tetanospasmin) Proteus mirabilis Neurotoxin Staphylococcus aureus Alpha toxin (alpha lysin) Yersinia pestis Murine toxin Snake toxins Bungarus caeruleus Caeruleotoxin Bungarus multicinctus Beta-bungarotoxin (phospholipase) Crotalus spp. Crotoxin (phospholipase) Dendroaspis viridis Neurotoxin Naja naja varieties Neurotoxin Notechia scutatus Notexin (phospholipase) Oxyuranus scutellatus Taipoxin Invertebrate toxins Chironex fleckeri Neurotoxin Androctnus australis Neurotoxin Centruroides sculpturatus Neurotoxin (4) Sequences for oxygen labile cytolysins

. Sequence Source Toxin Name Bacillus alve Alveolysin Bacillus cereus Cereolysin Bacillus laterosporus Laterosporolysin Bacillus thuringiensis Thuringiolysin Clostridium bifermentans Lysin Clostridium botulinum Lysin Clostridium caproicum Lysin Clostridium chauvoei Delta-toxin Clostridium histolyticum Epsilon-toxin Clostridium novyi Gamma-toxin Clostridium oedematiens Delta-toxin Clostridium perfringens Theta-toxin (Perfringolysin) Clostridium septicum Delta-toxin Clostridium sordelliiLysin Clostridium tetani Tetanolysin

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 Listeria monocytogenes Listeriolysin (A B) Streptococcus pneumoniae Pneumolysin Streptococcus pyogene Streptolysin O (SLO) (5) Sequences for toxins affec ting membrane function.

Sequence Source Toxin Name Bacillus anthracis Edema factor (Factors I II); Lethal factor (Factors II III) Bacillus cereus Enterotoxin (diarrheagenic toxin, mouse lethal factor) Bordetella pertussis Adenylate cyclase (Heat-labile factor); Pert ussigen (pertussis toxin, islet activating factor, histamine sensitizing factor , lymphocytosis promoting factor) Clostridium botulinum C2 toxin Clostridium difficile Enterotoxin (toxin A) Clostridium perfringens Beta-toxin; Delta-toxin Escherichia coli & other Enterobacteriaceae spp. Heat-labile enterotoxins (LT); Heat-stable enterotoxins (STa, ST1 subtypes ST1a ST1b; also STb, STII) Legionella pneumophila Cytolysin Vibrio cholerae & Vibrio mimicus Cholera toxin (choleragen) (6) Sequences that affect membrane integrity.

Sequence Source Toxin Name Clostridium bifermentans & other Clostridium spp Lecithinase Clostridium perfringens Alpha-toxin (phospholipase C, lecithinase); Enterotoxin Corynebacterium pyogenes & other Corynebacterium spp. Cytolysin (phospholipase C), Ovis toxin (sphingomyelinase D) Staphylococcus aureus Beta-lysin (beta toxin) (7) Sequences that are general cytotoxins.

Sequence Source Toxin Name Adenia digitata Modeccin Aeromonas hydrophila Aerolysin (beta-lysi n, cytotoxic lysin) Clostridium difficile Cytotoxin (toxin B) Clostridium perfringens Beta-toxin; Epsilon-toxin; Kappa-toxin Escherichia coli & other Enterobacteriaceae spp. Cytotoxin (Shiga-like toxin, Vero cell toxin) Pseudomonas aeruginosa Proteases Staphylococcus aureus Gamma lysin (Gamma toxin); Enterotoxins (SEA, SEB, SEC, SED SEE); Pyrogenic exotoxins A B; Toxic shock syndrome toxins (TSST-1) Staphylococcus aureus & Pseudomonas aeruginosa Leucocidin (leukocidin, cytotoxin) Streptococcus pyogenes Streptolysin S (SLS); Erythrogenic toxins (scarlet fever toxins, pyrogenic exotoxins) Yersinia enterocolitica Heat-stable enterotoxins (ST) 

### § 725.422 Physical containmen t and control technologies.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 The manufacturer must meet all of the following criteri a 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 im plemented procedures for the safety of personnel and control of hygiene. (d) Use inactivation procedures demonstrated and documen ted 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 viab le microbial populations inaerosols and exhaust gases released from the structure, and document use of such features. (f) Use systems for controlling dissemination of the new microorganism through othe r routes, and document use of such features. (g) Have in place emergency clean-up procedures. 

### § 725.424 Requirements for the Tier I exemption. (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 followi ng 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 descr ibed 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 reco rdkeeping requirements of §725.65 and maintains records for the initial and subsequent uses of the new microor ganism 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.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (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 descri bed in §725.422, including the provision in paragraph (a)(3) of this section. (5) The site of waste disposal and the type of permits for disposal, the permit numbers and the institutions issuing the permits. (6) The certification statement required in §725.25(b). Certif ication of submission of test data is not required for the Tier I exemption. 

### § 725.426 Applicability of the Tier I exemption. 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 a ll cases in compliance with §§725. 420, 725.421, and 725.422. 

### § 725.428 Requirements for the Tier II exemption. 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 th is part if all of the following conditions are met: (a) The recipient microorganism is listed in a nd 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 fac ilities 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. 

### § 725.450 Procedural requirements for the Tier II exemption. 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 exem ption, 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.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (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 we ll 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 s ubpart must comply with the recordkeeping requirements of §725.65. In addition, the submitter should maintain reco rds 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 exemp tion request including the criteria for the recipient microorganism, the introduced genetic material, the physical containment and control technologies. 

### § 725.455 Information to be included in the Tier II exemption request. 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 (incl uding 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 substan tiated 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 f unction 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 pe r 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 pro cess, 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.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (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/safe guards to prevent and mitigate accident al releases to the workplace and the environment. (2) Certification of those elements of the containment criteria described in §725.422 with which the manufacturer is in compliance, including stating by number the elemen ts with which the manufacturer is in full compliance. (e) The site of waste disposal and the type of permits for disposal, the permit numbers and the institutions issuing the permits. (f) The certification statement required in §725.25(b). Certifi cation of submission of test data is not required for the Tier II exemption. 

### § 725.470 EPA review of the Tier II exemption request. General procedures for review of a ll submissions under this part are c ontained in §§725.28 through 725.60. In addition, the following procedures apply to EPA reviewof 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 exte nds 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 th e 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 revi ew, because the microorganism does not meet the criteria under §725.428 or the Administrator, or a designee, decides that there is insufficient in formation 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 Admini strator, or a designee will notify the manufacturer or importer by telephone, followed by a letter, that the requ est has been denied. The letter will explain reasons for the denial. (3) If the request is denied, the manufacturer or impor ter 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 Agency will either approve or deny the request. (2) In approving a request, EPA may impose any restricti ons necessary to ensure that the microorganism will not present an unreasonable risk of injury to health and the environment as a result of general commercial use.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (f) EPA may seek to enjoin the manufacture or import of a mi croorganism in violation of this subpart, or act to seize any microorganism manufactured or imported in viola tion of this section or take other actions under the authority of sections 7 or 17 of the Act. (g) A manufacturer or importer may only proceed after receipt of EPA approval. 

### Subparts H–K [Reserved] Subpart L—Additional Procedures for Reporting on Significant New Us es of Microorganisms § 725.900 Scope and purpose. (a) This subpart describes additional provisions governing su bmission 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 describ ed 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 si gnificant new uses of microorganisms are described in §725.950. (e) Section 725.975 describes how EPA w ill 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 subm ission 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 id entified 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 al so apply to subparts L and M of this part. For purposes of subparts L and M of this part, wherever the words “micr oorganism” 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 govern. 

### § 725.910 Persons excluded from reporting significant new uses. (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 requi red 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:

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (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 sec tion 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 specifi c 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 know ledge 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 require d to submit a MCAN if that person can document each of the following: (1) That the person does not know the specific microorgani sm 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 h as knowledge that a recipient of the microorganism is engaging in a significant new use of that microorgani sm designated in that section without submitting a MCAN under this part, the person is required to cease supplying the microorganism to that recipient and to submit a MCAN for that microorganism and significant new use, unless the person is able to document each of the following: (i) That the person has notified the recipient and EPAenforcement authorities (at the address in paragraph (d)(1)(iii) of this section), in writing within 15 working days of the time the person develops knowledge that the recipient is engaging in a significant new use, that th e recipient is engaging in a significant new use without submitting a MCAN. (ii) That, within 15 working days of notifying the recipient as described in paragraph (d)(1)(i) of this section, the person received from the recipient, in writing, a statement of assurance that the recipient is aware of the terms of the applicable section in subpart M of this part and will not engage in the significant new use. (iii) That the person has promptly provided EPA enforcem ent authorities with a copy of the recipient's statement of assurance described in paragraph (d)(1)(ii) of this sec tion. The copy must be sent to the Director, Office of Compliance (2221A), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. (2) If EPA notifies the manufacturer, importer, or processor that the recipient is engaging in a significant new use after providing the statement of assurance described in paragraph (d)(1)(ii) of this section and without submitting a MCAN under this part, the manufacturer, importer, or processor shall immediately cease distribution to that recipient until the manufacturer, importer, or processor or the recipient has submitted a MCAN under this part and the MCAN review period has ended. (3) If, after receiving a statement of assurance from a recipient under paragraph (d)(1)(ii) of this section, a manufacturer, importer, or processor has knowledge that the r ecipient is engaging in a significant new use without

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 submitting a MCAN under this part, the manufacturer, importer, or processor must immediately cease distributing the microorganism to that recipient and notify EPA enfo rcement authorities at the address identified in paragraph (d)(1)(iii) of this section. The manufacturer, importer, or processor may not resume distribution to that recipient until any one of the following has occurred: (i) The manufacturer, importer, or processor has submitte d a MCAN under this part and the MCAN review period has ended. (ii) The recipient has submitted a MCAN under th is part and the MCAN review period has ended. (iii) The manufacturer, importer, or processor has receiv ed notice from EPA enforcement authorities that it may resume distribution to that recipient. 

### § 725.912 Exemptions. 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 speci fic 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 in clude the information and test data specified in section 5(d)(1) of the Act. For purposes of this exemption, the sp ecific 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 id entifies the microorganism, §§725.105 and 725.910 apply and §725.920 continues to apply. EPA will provide the MCAN submitter with written notif ication 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 envi ronment under reasonably foreseeable circumstances, or (2) EPA and the person negotiate a consen t 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 orde r 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. 

### § 725.920 Exports and imports. (a) Exports. Persons who intend to export a microorganism identifie d in subpart M of this part, or in any proposed rule which would amend subpart M of this part, are subj ect to the export notification provisions of section 12(b) of the Act. The regulations that interpret secti on 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 th e 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.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 

### § 725.950 Additional recordkeeping requirements. 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 un der this section may include the following: (1) Records documenting the information contained in the MCAN submitted to EPA. (2) Records documenting the manufacture and importati on volume of the microorganism and the corresponding dates of manufacture and import. (3) Records documenting volumes of the microorgani sm 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 manufactur e 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. 

### § 725.975 EPA approval of alternative control measures. (a) In certain sections of subpart M of this part, si gnificant new uses for the id entified microorganisms are described as the failure to establish and implement progra ms 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 re lease 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 inte nd 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 determina tion of equivalency to EPA under this part , unless allowed by §725.25(c) (1), (2), or (3), must submit the request to EPA ( via EPA's Central Data Exchange ( CDX) using EPA

provided e-PMN software

. in the manner set forth in §725.25(c). See 40 CFR 720.40(a)(2)( iv ii ) for information on how to obtain e-PMN software. Support documents relate d to these requests must also be submitted to EPA via CDX using e-PMN software. If submitted on paper, requests must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

– 0001; ATTN: SNUR Equivalency Determination or submitted via courier to the Environmental Protection Agency, OPPT D ocument Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW ., Rm. 6428, Washington, DC 20004; ATTN: SNUR Equivalency Determination. Optical discs containing el ectronic requests must be submitted by courier to the Environmental Protection Agenc y, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: SNUR Equivalency Determination. A request for a determination of equiva lency must contain: (1) The name of the submitter.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (2) The specific identity of the microorganism. (3) The citation for the specific section in subpart M of th is 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 expos ure control measures or environmental release control measures. (6) A detailed analysis explaining why such alternative control measures provi de 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 wh ich the request is being submitted. (7) The data and information described in §§725.155 and 725.160. If such dataand information have already been submitted to EPA's Office of Pollution Prevention and Toxics, the submitter need only document that it was previously submitted, to whom, and the date it was submitted. (c) Requests for determinations of e quivalency will be reviewed by EPA within 45 days. Determinations under this paragraph will be made by the Director, or a designee. Notice of the results of such determinations will be mailed to the submitter. (d) If EPA notifies the submitter under para graph (c) of this section that EPA ha s determined that the alternative control measures provide substantially the same degree of protection as the specified control measures identified in the specific section of subpart M of this part which pert ains to the microorganism for which the request is being submitted, the submitter may commence manufacture, impor t, or processing in accordance with the specifications for alternative worker exposure control measures or e nvironmental release control measures identified in the submitter's request, and may alter any co rresponding notification to workers to reflect such alternative controls. Deviations from the activities described in the EPA notification constitute a significant new use and are subject to the requirements of this part. [62 FR 17932, April 11, 1997, as amended at 75 FR 790, Jan. 6, 2010] 

### § 725.980 Expedited procedures for issuing signif icant new use rules for microorganisms subject to section 5(e) orders. (a) Selection of microorganisms. (1) In accordance with the expedited pro cess 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 th e 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 additi onal activities as significant new uses which will be subject to notification.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (2) Significant new use requirements and other specific re quirements 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 micr oorganism, 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 th ree processes: direct final rulemaking, interim final rulemaking, or notice and comment rulemaking. EPA w ill use the direct final rulemaking process to issue significant new use rules unless it determines that, in a particular case, one of the other processes is more appropriate. (2) Notice in the Federal Register. Federal Register documents issued to propose or establish significant new uses under this section will contain the following: (i) The microorganism identity or, if its specific iden tity is claimed confidential, an appropriate generic microorganism name and an accession number assigned by EPA. (ii) The MCAN number. (iii) A summary of EPA's findings under section 5(e)(1)(A ) of the Act for the final order issued under section 5(e). (iv) Designation of the significant new uses subject to, or proposed to be subject to, notification and any other applicable requirements. (v) Any modification of subpart L of this part applicable to the specific microorganism and significant new uses. (vi) If the Federal Register document establishes a final rule, or notifies the public that a final rule will not be issued after public comment has b een received, the document will describe comments received and EPA's response. (3) Direct final rulemaking. (i) EPA will use direct final rulemaking to issue a significant new use rule, when specific requirements will be based on and be consistent w ith the provisions included in the final order issued for the microorganism under section 5(e) of the Act. EPA will issu e a final rule in the Federal Register following its decision to develop a significant new use rule unde r this section for a specific new microorganism. (ii) The Federal Register document will state that, unless written notice is received by EPA within 30 days of publication that someone wishes to submit adverse or criti cal comments, the rule will be effective 60 days from the date of publication. The written notice of intent to submit adverse or critical comments should state which SNUR(s) will be the subject of the adverse or critical comments, if several SNURs are established through the direct final rule. If notice is received within 30 days th at someone wishes to submit adverse or critical comments, the section(s) of the direct final rule containing the SNUR (s) for which a notice of intent to comment was received will be withdrawn by EPA issuing a document in the final rule section of theFederal Register,and a proposal will be published in the proposed rule section of theFeder al Register.The proposal will establish a 30–day comment period.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (iii) If EPA, having considered any timely comments subm itted in response to the proposal, decides to establish notification requirements under this section, EPA will issue a final rule adding the microorganism to subpart M of this part and designating the significant new uses subject to notification. (4) Interim final rulemaking. (i) EPA will use the interim final rulema king procedure to issue a significant new use rule, when specific requirements will be based on and be consistent with the provi sions included in the final order issued for the microorganism under section 5(e) of th e Act. The Agency will issue an interim final rule in the Federal Register following its decision to de velop a significant new use rule for a specific new microorganism. The document will state EPA's reasons for using the interim final rulemaking procedure. (A) The significant new use rule will take effect on the date of publication. (B) Persons will be given 30 days from the date of publication to submit comments. (ii) Interim final rules issued under this section shall cease to be in effect 180 days after publication unless, within the 180–day period, EPA issues a final rule in the Federa l Register responding to any written comments received during the 30–day comment period specified in paragra ph (c)(4)(i)(B) of this section and promulgating final significant new use notification requirements and other requirements for the microorganism. (5) Notice and comment rulemaking. (i) EPA will use a notice and comment procedure to issue a significant new use rule, when EPA is designating additional activities whic h are not provisions included in the final order issued for the microorganism under section 5(e) of the Act as signi ficant new uses which will be subject to notification. EPA will issue a proposal in the Federal Register fo llowing its decision to develop a significant new use rule under this section for a specific new microorganism. Pers ons will be given 30 days to comment on whether EPA should establish notification requirements for the microorganism under this part. (ii) If EPA, having considered any timely comments, d ecides to establish notification requirements under this section, EPA will issue a final rule adding the microorganism to subpart M of this part and designating the significant new uses subject to notification. (d) Schedule for issuing significant new use rules. (1) Unless EPA determines that a significant new use rule should not be issued under this section, EPA will issue a propo sed rule, a direct final rule, or an interim final rule within 180 days of receipt of a valid notice of commencement under §725.190. (2) If EPA receives adverse or critical significant comments following publication of a pr oposed or interim final rule, EPA will either withdraw the rule or i ssue a final rule addressing the comments received. 

### § 725.984 Modification or revocation of certain notification requirements. (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 un der 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 pr ovide a reasonable basis for concluding that activities designated as significant new uses of the microorganism w ill not present an unreasonable risk of injury to health or the environment. (2) EPA has promulgated a rule under section 4 or 6 of th e 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.

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 (3) EPA has received MCANs for some or all of th e activities designated as significant new uses of the microorganism and, after reviewing such MCANs, conclude d 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 reexamin ed the test data or other information supporting its finding under section 5(e)(1)(A)(ii)(I) of the Act and has c oncluded that a rational basis no longer exists for the findings that activities involving the microorganism may pr esent 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 withapplicable 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 occur either at EPA's initiative or in response to a written request. (1) Any affected person may request modification or re vocation 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. The request must be accompanied by information sufficien t to support the request. Persons submitting a request 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. (1) Any affected person may request modification or re vocation of significant new use notification requirements for a microorganism that has been added to subpart M of this part using the pro cedures described in §725.980 by writing to the Director, or a designee, and stating the basis for such request . The request must be accompanied by information sufficient to support the request. Pe rsons submitting a request to EPA under this part , unless allowed by §725.25(c)(1), (c)(2), or (c)(3), must submit the request to EPA ( via EPA's Central Data Exchange ( CDX) using EPA

- provided e-PMN reporting software in the manner set forth in §725.25(c) . See 40 CFR 720.40(a)(2)( iv ii ) for information on how to obtain the e-PMN software. Support documents related to these requests must also be submitted to EPA via CDX using e-PMN software. Paper requests must be submitted either via U.S. mail to the Document Control Office (D CO) (7407M), Office of Pollution Prevention and T oxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

– 0001; ATTN: Request to Amend SNUR or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constituti on Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: Request to Amend SNUR. Optical discs containing electronic requests must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constituti on Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: Request to Amend SNUR. (2) The Director, or a designee, will consider the request, make a determination whether to initiate rulemaking to modify the requirements, and notify the requester of that determination by certified letter. If the request is denied, the letter will explain why EPA has concluded that the significant new use notification requirements for that microorganism should remain in effect. (3) If EPA concludes that significant new use notificati on requirements for a microorganism should be limited or revoked, EPA will propose the changes in a notice in theF ederal Register,briefly describe the grounds for the action, and provide interested parties an opportunity to comment. [62 FR 17932, April 11, 1997, as amended at 75 FR 790, Jan. 6, 2010] 

### Subpart M—Significant New Uses for Specific Microorganisms

### Proposed Rule; Electronic Reporting Under the Toxic Substances Control Act (RIN 2070-AJ75) Demonstration of Proposed Revisions to Existing Rules – 40 CFR 725 

### § 725.1000 Scope. This subpart identifies uses of microorganisms which EPA has determined to be significant new uses under the authority of section 5(a)(2) of th e Toxic Substances Control Act. 

### § 725.1075 Burkholderia cepacia complex. (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 researc h and development in the degradation of chemicals via injection into subsurface groundwater. (b) [Reserved] [68 FR 35320, June 13, 2003]