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.

(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:

(c) Where to submit information under this part. MCANs and exemption requests, and any support documents related to these submissions, may only be submitted in a manner set forth in this paragraph. MCANs and exemption requests, and any related support documents, must be generated, completed, and submitted to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.

(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 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 person, (e.g., a supplier or a toll manufacturer) to report some of the information required in the MCAN to EPA on its behalf. The manufacturer or importer should indicate in a cover letter accompanying the MCAN which information will be supplied by another person and identify that other person as a joint submitter where indicated in their MCAN. The other person supplying information (i.e., the joint submitter) may submit the information to EPA either in the MCAN or a Letter of Support, except that if the joint submitter is not incorporated, licensed, or doing business 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.

(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.

(i) Fees. Persons submitting MCANs and exemption requests to EPA under this part are subject to the applicable fees and conditions specified in §§ 700.40, 700.45(c), and 700.49 of this chapter.

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.

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.

(a) EPA will acknowledge receipt of each submission by sending a letter via CDX or U.S. mail to the submitter that identifies the number assigned to each MCAN or exemption request and the date on which the review period begins. The review period will begin on the date the MCAN or exemption request is received by the Office of Pollution Prevention and Toxics Document Control Officer.

(b) The acknowledgement does not constitute a finding by EPA that the submission is in compliance with this part.

(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.

(a) A submission under this part is not complete, and the review period does not begin, if:

(1) The wrong person files the submission.

(2) The submitter does not attach and sign the certification statement as required by § 725.25(b).

(3) Some or all of the information in the submission or any attachments are not in English, except for published scientific literature.

(4) The submitter does not provide information that is required by sections 5(d)(1)(B) and (C) of the Act and § 725.160 or 725.260, as appropriate.

(5) The submitter does not provide information required by § 725.25, § 725.155, § 725.255, § 725.355, or § 725.455, as appropriate, or indicate that it is not known to or reasonably ascertainable by the submitter.

(6) The submitter has asserted confidentiality claims and has failed to:

(i) Submit a second copy of the submission with all confidential information deleted for the public file, as required by § 725.80(b)(2).

(ii) Comply with the substantiation requirements as described in § 725.94.

(7) The submitter does not include any information required by section 5(b)(1) of the Act and pursuant to a rule promulgated under section 4 of the Act, as required by § 725.25(f).

(8) The submitter does not submit data which the submitter believes show that the microorganism will not present an unreasonable risk of injury to health or the environment, if EPA has listed the microorganism under section 5(b)(4) of the Act, as required in § 725.25(g).

(9) The submitter does not remit the fees required by § 700.45(c) of this chapter.

(10) The submitter does not include an identifying number and a payment identity number.

(11) The submitter does not submit the notice in the manner set forth in § 725.25(c).

(b)(1) If EPA receives an incomplete submission under this part, the Director, or a designee, will notify the submitter within 30 days of receipt that the submission is incomplete and that the review period will not begin until EPA receives a complete submission.

(2) If EPA obtains additional information 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.

(a) During the review period, if a submitter possesses, controls, or knows of new information that materially adds to, changes, or otherwise makes significantly more complete the information included in the MCAN or exemption request, the submitter must send that information within 10 days of receiving the new information, but no later than 5 days before the end of the review period. The new information must be sent in the same manner the original notice or exemption was sent, as described in § 725.25(c)(1), (c)(2), and (c)(3).

(b) The new submission must clearly identify the submitter, the MCAN or exemption request to which the new information is related, and the number assigned to that submission by EPA, if known to the submitter.

(c) If the new information becomes available during the last 5 days of the review period, the submitter must immediately inform the EPA contact for that submission by telephone of the new information.

(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.

(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.

(a) A submitter may voluntarily suspend the running of the review period if the Director, or a designee, agrees. If the Director does not agree, the review period will continue to run, and EPA will notify the submitter. A submitter may request a suspension at any time during the review period. The suspension must be for a specified period of time.

(b)(1) Request for suspension. A request for suspension may only be submitted in a manner set forth in this paragraph. The request for suspension also may be made orally, including by telephone, to the submitter's EPA contact for that notice, subject to paragraph (c) of this section.

(2) Submission of suspension notices. EPA will accept requests for suspension only if submitted in accordance with this paragraph. Requests for suspension, must be generated, completed, and submitted to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.

(c) An oral 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 CDX submission by EPA.

(a) At any time during the review period, EPA may unilaterally determine that good cause exists to extend the review period specified for MCANs, or the exemption requests.

(b) If EPA makes such a determination, EPA:

(1) Will notify the submitter that EPA is extending the review period for a specified length of time and state the reasons for the extension.

(2) For MCANs, EPA may issue a notice for publication in the Federal Register which states that EPA is extending the review period and gives the reasons for the extension.

(c) The total period of the extension may be for a period of up to the same length of time as specified for each type of submission in § 725.50. If the initial extension is for less than the total time allowed, EPA may make additional extensions. However, the sum of the extensions may not exceed the total allowed.

(d) The following are examples of situations in which EPA may find that good cause exists for extending the review period:

(1) EPA has reviewed the submission and is seeking additional information.

(2) EPA has received significant additional information during the review period.

(3) The submitter has failed to correct a submission after receiving EPA's request under § 725.32.

(4) EPA has reviewed the submission and determined that there is a significant possibility that the microorganism will be regulated under section 5(e) or section 5(f) of the Act, but EPA is unable to initiate regulatory action within the initial review period.

(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 manner set forth in this paragraph. The withdrawal is effective upon receipt of the CDX submission by EPA.

(2) Submission of withdrawal notices. EPA will accept statements of withdrawal only if submitted in accordance with this paragraph. Statements of withdrawal must be generated, completed, and submitted to EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.

(b) If a manufacturer, importer, or processor who withdrew a submission later resubmits a submission for the same microorganism, a new review period begins.

(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.

(a) Submission. (1) Any manufacturer or importer of a new microorganism may request, under TSCA section 5(h)(4), an exemption, in whole or in part, from this part by sending a Letter of Application in the manner set forth in § 725.25(c).

(2) General provisions. The Letter of Application should provide information to show that any activities affected by the requested exemption will not present an unreasonable risk of injury to health or the environment. This information should include data described in the following paragraphs.

(i) The effects of the new microorganism on health and the environment.

(ii) The magnitude of exposure of human beings and the environment to the new microorganism.

(iii) The benefits of the new microorganism for various uses and the availability of substitutes for such uses.

(iv) The reasonably ascertainable economic consequences of granting or denying the exemption, including effects on the national economy, small business, and technological innovation.

(3) Specific requirements. In addition to the requirements of paragraph (a)(2) of this section, the specific information requirements of the relevant subpart under which the exemption is sought should be met.

(i) Exemption from MCAN reporting under subpart D. Information requirements are set forth in §§ 725.155 and 725.160.

(ii) Exemption from TERA reporting under subpart E. Information requirements are set forth in §§ 725.255 and 725.260.

(iii) Listing a recipient microorganism as eligible for exemption under subpart G. Information regarding the following criteria should be addressed in an application to list a recipient microorganism under § 725.420:

(A) Identification and classification of the microorganism using available genotypic and phenotypic information;

(B) Information to evaluate the relationship of the microorganism to any other closely related microorganisms which have a potential for adverse effects on health or the environment;

(C) A history of safe commercial use for the microorganism;

(D) 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 Chemical Safety and Pollution Prevention 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.

(a) Failure to comply with any provision of this part is a violation of section 15 of the Act (15 U.S.C. 2614).

(b) A person who manufactures or imports a microorganism before a MCAN is submitted and the MCAN review period expires is in violation of section 15 of the Act even if that person was not required to submit the MCAN under § 725.105.

(c) Using a microorganism which a person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of section 5 of the Act or this part is a violation of section 15 of the Act (15 U.S.C. 2614).

(d) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).

(e) Failure or refusal to permit entry or inspection as required by section 11 of the Act is a violation of section 15 of the Act (15 U.S.C. 2614).

(f) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who submit materially misleading or false information in connection with the requirements of any provision of this part may be subject to penalties calculated as if they never filed their submissions.

(g) EPA may seek to enjoin the manufacture or processing of a microorganism in violation of this part or act to seize any microorganism manufactured or processed in violation of this part or take other actions under the authority of section 7 of the Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).

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.