Loading (50 kb)...'
United States Regulations
40 CFR PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
Source: 62 FR 17932, April 11, 1997, unless otherwise noted.
Subpart A—General Provisions and Applicability
§ 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 jurisdiction for commercial purposes, including research and development for commercial purposes. New microorganisms for which manufacturers and importers are required to report under section 5(a)(1)(A) of TSCA are those that are intergeneric. In addition, under section 5(a)(1)(B) of TSCA, manufacturers, importers, and processors may be required to report for any microorganism that EPA determines by rule is being manufactured, imported, or processed for a significant new use.
(b) Any manufacturer, importer, or processor required to report under section 5 of TSCA (see §725.100 for new microorganisms and §725.900 for significant new uses) must file a Microbial Commercial Activity Notice (MCAN) with EPA, unless the activity is eligible for a specific exemption as described in this part. The general procedures for filing MCANs are described in subpart D of this part. The exemptions from the requirement to file a MCAN are for certain kinds of contained activities (see §§725.424 and 725.428), test marketing activities (see §725.300), and research and development activities described in paragraph (c) of this section.
(c) Any manufacturer, importer, or processor required to file a MCAN for research and development (R&D) activities may instead file a TSCA Experimental Release Application (TERA) for a specific test (see §725.250). A TERA is not required for certain R&D activities; however a TERA exemption does not extend beyond the research and development stage, to general commercial use of the microorganism, for which compliance with MCAN requirements is required. The TERA exemptions are for R&D activities subject to other Federal agencies or programs (see §725.232), certain kinds of contained R&D activities (see §725.234), and R&D activities using certain listed microorganisms (see §725.238).
(d) New microorganisms will be added to the Inventory 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 actually begun. 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 specified in this section. In addition, the following definitions apply to this part:
Consolidated microbial commercial activity notice or consolidated MCAN means any MCAN submitted to EPA that covers more than one microorganism (each being assigned a separate MCAN number by EPA) as a result of a prenotice agreement with EPA.
Containment and/or inactivation controls means any combination of engineering, mechanical, procedural, or biological controls designed and operated to restrict environmental release of viable microorganisms from a structure.
Director means the Director of the EPA Office of Pollution Prevention and Toxics.
Exemption request means any application submitted to EPA under subparts E, F, or G of this part.
General commercial use means use for commercial purposes other than research and development.
Genome means the sum total of chromosomal and extrachromosomal genetic material of an isolate and any descendants derived under pure culture conditions from that isolate.
Health and safety study of a microorganism or health and safety study means any study of any effect of a microorganism or microbial mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a microorganism or microbial mixture, toxicological, clinical, and ecological, or other studies of a microorganism or microbial mixture, and any test performed under the Act. Microorganism identity is always part of a health and safety study of a microorganism.
(1) It is intended that the term “health and safety study of a microorganism” be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a microorganism or microbial mixture on health or the environment is also included. Any 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, critical 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, carcinogenicity, or teratogenicity; dermatoxicity; cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects.
(iii) Assessments of human and environmental exposure, 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 environment 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 organisms of different taxonomic genera.
(1) The term “intergeneric microorganism” includes a microorganism 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 include a microorganism which contains introduced genetic material consisting of only well-characterized, non-coding regulatory regions from another genus.
Introduced genetic material means genetic material that is added to, and remains as a component of, the genome of the recipient.
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 development or as an intermediate.
(2) The term also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another microorganism or microbial mixture, 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 microorganisms 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 the 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 nucleotides do not code for protein, peptide, or functional ribonucleic acid molecules.
(2) The regulatory region solely controls the activity of other 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”) means 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.
Structure means a building or vessel which effectively surrounds 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 associated with the microorganism which is used under his or her supervision,
(2) Who is responsible for enforcing appropriate methods of conducting scientific experimentation, analysis, or microbiological research to minimize such risks, and
(3) Who is responsible for the safety assessments and clearances 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 for a research and development activity, which is not eligible for a full exemption from reporting under §725.232, 725.234, or 725.238, submitted to EPA in accordance with subpart E of this part.
Well-characterized for introduced genetic material means that the following have been determined:
(1) The function of all of the products expressed from the structural gene(s).
(2) The function of sequences that participate in the regulation of expression of the structural gene(s).
(3) The presence or absence of associated nucleotide sequences and their associated functions, where associated nucleotide sequences are those sequences needed to move genetic material including linkers, homopolymers, adaptors, transposons, insertion sequences, and restriction enzyme sites.
§ 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, are subject to the requirements of this part.
(b) Microorganisms automatically included on the Inventory. Microorganisms that are not intergeneric are automatically included on the Inventory.
(c) Microorganisms not subject to this part. The following microorganisms are not subject to this part, either because they are not subject to jurisdiction under the Act or are not subject to reporting under section 5 of the Act.
(1) Any microorganism which would be excluded from the definition of “chemical substance” in section 3 of the Act and §720.3(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 substances which are part of the microbial mixture.
(3) Any microorganism that is manufactured and processed solely for export if the following conditions are met:
(i) The microorganism is labeled in accordance with section 12(a)(1)(B) of the Act, when the microorganism is distributed in commerce.
(ii) The manufacturer and processor can document at the commencement of manufacturing or processing that the person to whom the microorganism will be distributed intends to export it or process it solely for export as defined in §721.3 of this chapter.
§ 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 paragraph (b) of this section will be used to specifically describe an individual microorganism on the Inventory. Submitters must provide the supplemental information required by paragraph (b) of this section to the extent necessary to enable a microorganism to be accurately and unambiguously identified on the Inventory.
(a) Taxonomic designation. The taxonomic designation of a microorganism must be provided for the donor organism and the recipient microorganism to the level of strain, as appropriate. These designations must be substantiated by a letter from a culture collection, literature references, or the results of tests conducted for the purpose of taxonomic classification. Upon EPA's request to the submitter, data supporting the taxonomic designation must be provided to EPA. The genetic history of the recipient microorganism should be documented back to the isolate from which it was derived.
(b) Supplemental information. The supplemental information described in paragraphs (b)(1) and (b)(2) of this section is required to the extent that it enables a microorganism to be accurately and unambiguously identified.
(1) Phenotypic information. Phenotypic information means pertinent traits that result from the interaction of a microorganism's genotype and the environment in which it is intended to be used and may include intentionally added biochemical and physiological traits.
(2) Genotypic information. Genotypic information means the pertinent and distinguishing genotypic characteristics of a microorganism, such as the identity of the introduced genetic material and the methods used to construct the reported microorganism. This also may include information on the vector construct, the cellular location, and the number of copies of the introduced genetic material.
§ 725.15 Determining applicability when microorganism 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 consulting the Inventory or the microorganisms and uses specified in §725.239 or in subpart M of this part. This section establishes procedures for EPA to assist persons in determining whether the microorganism or the use is listed on the Inventory, in §725.239 or in subpart M of this part.
(1) Confidential identity or use. In some cases it may not be possible to directly determine if a specific microorganism is listed, because portions of that entry may contain generic information to protect confidential business information (CBI). If any portion of the microorganism's identity or use has been claimed as CBI, that portion does not appear on the public version of the Inventory, in §725.239 or in subpart M of this part. Instead, it is contained in a confidential version held in EPA's Confidential Business Information Center (CBIC). The public versions contain generic information which masks the confidential business information. A person who intends to conduct an activity involving a microorganism or use whose entry is described with generic information will need to inquire of EPA whether the unreported microorganism or use is on the confidential version.
(2) Uncertain microorganism identity. The current state of scientific knowledge leads to some imprecision in describing a microorganism. As the state of knowledge increases, EPA will be developing policies to determine whether one microorganism is equivalent to another. Persons intending to conduct activities involving microorganisms may inquire of EPA whether the microorganisms they intend to manufacture, 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 activity 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 supplemental information required by §725.12.
(ii) A signed statement certifying that the submitter intends to manufacture, import, or process the microorganism for commercial purposes.
(iii) A description of research and development activities conducted with the microorganism to date, demonstration of the submitter's ability to produce or obtain 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 was previously reviewed by EPA to the extent known by the submitter.
(v) A specific description of the major intended application or use of the microorganism.
(c) If an importer or processor cannot provide all the information 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 manufacturer, 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 compare this information to the information requested for the confidential microorganism under §725.85(b)(3)(iii).
(e) In order for EPA to make a conclusive determination 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 information to establish identity unambiguously. After sufficient information has been provided, EPA will inform the 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 reported 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 microorganism is on the Inventory, in §725.239, or in subpart M of this part.
(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 microorganism is subject to this part within 30 days after receipt of a complete submission under paragraph (b) of this section.
§ 725.17 Consultation with EPA.
Persons may consult with EPA, either in writing or by telephone, about their obligations under this part. Written consultation is preferred. Written inquiries should be sent to the following address: Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: Biotechnology Notice Consultation. Persons wishing to consult with EPA by telephone should call (202) 554–1404; hearing impaired TDD (202) 554–0551 or e-mail: TSCA-Hotline@epamail.epa.gov.
Subpart B—Administrative Procedures
§ 725.20 Scope and purpose.
This subpart describes general administrative procedures applicable to all persons who submit MCANs and exemption requests to EPA under section 5 of the Act for microorganisms.
§ 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 information as required for the appropriate submission under this part. Except as otherwise provided, each submission must include all referenced attachments. All information in the submission (unless certain attachments appear in the open scientific literature) must be in English. All information submitted must be true and correct.
(2) In addition to specific information required, the submitter should submit all information known to or reasonably ascertainable by the submitter that would permit EPA to make a reasoned evaluation of the human health and environmental effects of the microorganism and any microbial mixture or article that may contain the microorganism.
(b) Certification. Persons submitting MCANs and exemption requests to EPA under this part, and material related to their reporting obligations under this part, must attach the following statement to any information submitted to EPA. This statement must be signed and dated by an authorized official of the submitter:
I certify that to the best of my knowledge and belief: The company named in this submission intends to manufacture, import, or process for a commercial purpose, other than in small quantities solely for research and development, the microorganism identified in this submission. All information provided in this submission is complete and truthful as of the date of submission. I am including with this submission all test data in my possession or control and a description of all other data known to or reasonably ascertainable by me as required by 40 CFR 725.160 or 725.260.
(c) Where to submit information under this part. Persons submitting MCANs and exemption requests to EPA under this part, and material related to their reporting obligations under this part, must send them to: TSCA Document Processing Center (7407), Rm. L–100, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(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 extent such information is known to or reasonably ascertainable by the submitter.
(2) In accordance with §725.160 or 725.260, as appropriate, the 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 submit the MCAN or exemption request. Both the manufacturer or importer and the agent must sign the certification required in paragraph (b) of this section.
(2) A manufacturer or importer may authorize another person (e.g., a foreign manufacturer or supplier, or a toll manufacturer) to report some of the information required in the MCAN or exemption request to EPA on its behalf. If separate portions of a joint submission are not submitted together, the submitter must indicate which information will be supplied by another person and identify that person. The manufacturer or importer and any other person supplying the information must sign the certification required by paragraph (b) of this section.
(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 review 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 microorganism which is subject to the notification requirements of this part, and the microorganism is subject to a test rule 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 section 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 person 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 issued under section 5(b)(4) of the Act; and
(ii) Is not required by a rule issued under section 4 of the 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 paragraph (g)(1) of this section must be data which the person submitting the notice believes show that the manufacture, processing, distribution 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 that need not be submitted under this part:
(1) Data previously submitted to EPA. (i) A person need not submit any data previously 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 specified 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.
(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 submission of any data which relates only to exposure of humans or the environment outside the United States. This does not exclude nonexposure data such as data on health effects (including epidemiological studies), ecological effects, physical and chemical properties, or environmental fate characteristics.
§ 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 exemptions (TMEs) are described in §§725.350 and 725.355.
(d) Requirements specific to Tier I and Tier II exemptions for certain general commercial uses are described in §§725.424 through 725.470.
(e) Additional requirements specific to significant new uses for microorganisms are described at §725.950.
§ 725.28 Notice that submission is not required.
When EPA receives a MCAN or exemption request, EPA will review it to determine whether the microorganism is subject to the requirements of this part. If EPA determines that the microorganism is not subject to these requirements, EPA will notify the submitter that section 5 of the Act does not prevent the manufacture, import, or processing of the microorganism and that the submission is not needed.
§ 725.29 EPA acknowledgement of receipt of submission.
(a) EPA will acknowledge receipt of each submission by sending the submitter a letter that identifies the number assigned to each MCAN or exemption request and the date on which the review period begins. The review period will begin on the date the MCAN or exemption request is received by the Office of Pollution Prevention and Toxics Document Control Officer.
(b) The acknowledgement does not constitute a finding by EPA that the submission is in compliance with this part.
§ 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:
(1) Failure to date the submission.
(2) Typographical errors that cause data to be misleading or answers to any questions to be unclear.
(3) Contradictory information.
(4) Ambiguous statements or information.
(b) In the request to correct the submission, EPA will explain the action which the submitter must take to correct the submission.
(c) If the submitter fails to correct the submission within 15 days of receipt of the request, EPA may extend the review period.
§ 725.33 Incomplete submissions.
(a) A submission under this part is not complete, and the review period does not begin, if:
(1) The wrong person files the submission.
(2) The submitter does not attach and sign the certification statement as required by §725.25(b).
(3) Some or all of the information in the submission or any attachments are not in English, except for published scientific literature.
(4) The submitter does not provide information that is required by sections 5(d)(1)(B) and (C) of the Act and §725.160 or 725.260, as appropriate.
(5) The submitter does not provide information required by §725.25, 725.155, 725.255, 725.355, or 725.455, as appropriate, or indicate that it is not known to or reasonably ascertainable by the submitter.
(6) The submitter has asserted confidentiality claims and has failed to:
(i) Submit a second copy of the submission with all confidential information deleted for the public file, as required by §725.80(b)(2).
(ii) Comply with the substantiation requirements as described in §725.94.
(7) The submitter does not include any information required by section 5(b)(1) of the Act and pursuant to a rule promulgated under section 4 of the Act, as required by §725.25(f).
(8) The submitter does not submit data which the submitter believes show that the microorganism will not present an unreasonable risk of injury to health or the environment, if EPA has listed the microorganism under section 5(b)(4) of the Act, as required in §725.25(g).
(9) For MCANs, the submitter does not remit the fees required by §700.45(b)(1) or (b)(2)(vi) of this chapter.
(b)(1) If EPA receives an incomplete submission under this part, the Director, or a designee, will notify the submitter within 30 days of receipt that the submission is incomplete and that the review period will not begin until EPA receives a complete submission.
(2) If EPA obtains additional information 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 information and so notify the submitter.
(c) The notification that a submission is incomplete under paragraph (b) of this section will include:
(1) A statement of the basis of EPA's determination 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 EPA that a submission is incomplete, the submitter may file written objections requesting that EPA accept the submission as complete or modify the requirements necessary to complete the submission.
(e)(1) EPA will consider the objections filed by the submitter. 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 response to the objection, that the submission was complete, the review period will be deemed suspended 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 within the review period beginning on the date of the submission, the Director, or a designee, may inform the 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 requirements 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 materially false or misleading statements in information submitted under this part, EPA may find that the submission was incomplete from the date it was submitted, and take any other appropriate action.
§ 725.36 New information.
(a) During the review period, if a submitter possesses, controls, or knows of new information that materially adds to, changes, or otherwise makes significantly more complete the information included in the MCAN or exemption request, the submitter must send that information to the address listed in §725.25(c) within 10 days of receiving the new information, but no later than 5 days before the end of the review period.
(b) The new submission must clearly identify the submitter, the MCAN or exemption request to which the new information is related, and the number assigned to that submission by EPA, if known to the submitter.
(c) If the new information becomes available during the last 5 days of the review period, the submitter must immediately inform the EPA contact for that submission by telephone of the new information.
§ 725.40 Notice in the Federal Register.
(a) Filing of Federal Register notice. After EPA receives a MCAN or an exemption request under this part, EPA will issue a notice in the Federal Register including the information specified in paragraph (b) of this section.
(b) Contents of notice. (1) In the public interest, the specific microorganism identity listed in the submission will be published in the Federal Register unless the submitter has claimed the microorganism identity confidential. If the submitter claims confidentiality, a generic name will be published in accordance with §725.85.
(2) The categories of use of the microorganism will be published as reported in the submission unless this information is claimed confidential. If confidentiality is claimed, the generic information which is submitted under §725.88 will be published.
(3) A list of information submitted in accordance with §725.160(a), 725.255, 725.260, 725.355, or 725.455, as appropriate, will be published.
(4) The submitter's identity will be published, unless the submitter has claimed it confidential.
(c) Publication of exemption decisions. Following the expiration of the appropriate review period for the exemption request, EPA will issue a notice in the Federal Register indicating whether the request has been approved or denied and the reasons for the decision.
§ 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 review period under section 5(c) of the Act and §725.56.
(b) Exemption requests. The review period starts on the date the Document Control Officer receives a complete exemption request, or the date EPA determines the request is complete under §725.33, unless the Agency extends the review period under §725.56. The review periods for exemption requests run as follows:
(1) TERAs. The review period for TERAs is 60 days.
(2) TMEs. The review period for TMEs is 45 days.
(3) Tier II exemption requests. The review period for Tier II exemption requests is 45 days.
§ 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 continue to run, and EPA will notify the submitter. A submitter may request a suspension at any time during the review period. The suspension must be for a specified period of time.
(b) A request for suspension may be made in writing to the address listed in §725.25(c). The suspension also may be made orally, including by telephone, to the submitter's EPA contact for that submission. EPA will send the submitter a written confirmation that the suspension has been granted.
(1) An oral request may be granted for no longer than 15 days. To obtain a longer suspension, the Document Control Officer for the Office of Pollution Prevention and Toxics must receive written confirmation of the oral request. The review period is suspended as of the date of the oral request.
(2) If the submitter has not made a previous oral request, the running of the review period is suspended as of the date of receipt of the written request by the Document Control Officer for the Office of Pollution Prevention and Toxics.
§ 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 review period for a specified length of time and state the reasons for the extension.
(2) For MCANs, EPA may issue a notice for publication in the Federal Register which states that EPA is extending the review period and gives the reasons for the extension.
(c) The total period of the extension may be for a period of up to the same length of time as specified for each type of submission in §725.50. If the initial extension is for less than the total time allowed, EPA may make additional extensions. However, the sum of the extensions may not exceed the total allowed.
(d) The following are examples of situations in which EPA may find that good cause exists for extending the review period:
(1) EPA has reviewed the submission and is seeking additional information.
(2) EPA has received significant additional information during the review period.
(3) The submitter has failed to correct a submission after receiving EPA's request under §725.32.
(4) EPA has reviewed the submission and determined that there is a significant possibility that the microorganism will be regulated under section 5(e) or section 5(f) of the Act, but EPA is unable to initiate regulatory action within the initial review period.
§ 725.60 Withdrawal of submission by the submitter.
(a) A submitter may withdraw a submission during the review period. A statement of withdrawal must be made in writing to the address listed in §725.25(c). The withdrawal is effective upon receipt of the statement by the Document Control Officer.
(b) If a manufacturer, importer, or processor who withdrew a submission later resubmits a submission for the same microorganism, a new review period begins.
§ 725.65 Recordkeeping.
(a) General provisions. (1) Any person who submits a notice under this part must retain documentation of information in the submission, including:
(i) Any data in the submitter's possession or control; and
(ii) Records of production volume for the first 3 years of manufacture, import, or processing.
(2) Any person who submits a notice under this part must retain documentation of the date of commencement of testing, manufacture, import, or processing.
(3) Any person who is exempt from some or all of the reporting requirements of this part must retain documentation that supports the exemption.
(4) All information required by this section must be retained for 3 years from the date of commencement of each activity for which records are required under this part.
(b) Specific requirements. In addition to the requirements of paragraph (a) of this section, specific recordkeeping requirements included in certain subparts must also be followed.
(1) Additional recordkeeping requirements for activities conducted inside a structure are set forth in §725.235(h).
(2) Additional recordkeeping requirements for TERAs are set forth in §725.250(f).
(3) Additional recordkeeping requirements for TMEs are set forth in §725.350(c).
(4) Additional recordkeeping requirements for Tier I exemptions under subpart G of this part are set forth in §725.424(a)(5).
(5) Additional recordkeeping requirements for Tier II exemptions under subpart G of this part are set forth in §725.450(d).
(6) Additional recordkeeping requirements for significant new uses of microorganisms reported under subpart L of this part are set forth in §725.850. Recordkeeping requirements may also be included when a microorganism and significant new use are added to subpart M of this part.
§ 725.67 Applications to exempt new microorganisms from this part.
(a) Submission. (1) Any manufacturer or importer of a new microorganism may request, under section 5(h)(4) of the Act, an exemption, in whole or in part, from this part by sending a Letter of Application to the Chief, New Chemicals Branch, Chemical Control Division, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(2) General provisions. The Letter of Application should provide information to show that any activities affected by the requested exemption will not present an unreasonable risk of injury to health or the environment. This information should include data described in the following paragraphs.
(i) The effects of the new microorganism on health and the environment.
(ii) The magnitude of exposure of human beings and the environment to the new microorganism.
(iii) The benefits of the new microorganism for various uses and the availability of substitutes for such uses.
(iv) The reasonably ascertainable economic consequences of granting or denying the exemption, including effects on the national economy, small business, and technological innovation.
(3) Specific requirements. In addition to the requirements of paragraph (a)(2) of this section, the specific information requirements of the relevant subpart under which the exemption is sought should be met.
(i) Exemption from MCAN reporting under subpart D. Information requirements are set forth in §§725.155 and 725.160.
(ii) Exemption from TERA reporting under subpart E. Information requirements are set forth in §§725.255 and 725.260.
(iii) Listing a recipient microorganism as eligible for exemption under subpart G. Information regarding the following criteria should be addressed in an application to list a recipient microorganism under §725.420:
(A) Identification and classification of the microorganism using available genotypic and phenotypic information;
(B) Information to evaluate the relationship of the microorganism to any other closely related microorganisms which have a potential for adverse effects on health or the environment;
(C) A history of safe commercial use for the microorganism;
(D) Commercial uses indicating that the microorganism products might be subject to TSCA;
(E) Studies which indicate the potential for the microorganism to cause adverse effects to health or the environment; and
(F) Studies which indicate the survival characteristics 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 information available to EPA, the Assistant Administrator for Prevention, Pesticides and Toxic Substances makes a preliminary determination that the new microorganism will not present an unreasonable risk of injury to health or the environment, the Assistant Administrator will propose a rule to grant the exemption using the applicable procedures in part 750 of this chapter.
(2) Denial of the application. If the Assistant Administrator decides that the 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 unreasonable risk of injury to health or the environment.
(i) An unreasonable risk determination under the Act is an administrative judgment that requires balancing of the harm to health or the environment that a chemical substance 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 section 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 rulemaking proceeding described in paragraph (b)(1) of this section, that the new microorganism will not present an unreasonable 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 rulemaking 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.
§ 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 microorganism before a MCAN is submitted and the MCAN review period expires is in violation of section 15 of the Act even if that person was not required to submit the MCAN under §725.105.
(c) Using a microorganism which a person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of section 5 of the Act or this part is a violation of section 15 of the Act (15 U.S.C. 2614). (continued)