Terms used in this subpart shall, with the exception of those defined below, have the meaning set forth in the Act and in § 172.1.

Containment and inactivation controls means any combination of mechanical, procedural, or biological controls designed and operated to restrict environmental release of viable microorganisms from a facility.

Deliberately modified means the directed addition, rearrangement, or removal of nucleotide sequences to or from genetic material.

Introduction of genetic material means the movement of nucleotide sequences into a microorganism, regardless of the technique used.

Inversions of genetic material means the replacement of an internal section of a chromosome in the reverse orientation.

Microbial pesticide means a microbial agent intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, that:

(1) Is a eucaryotic microorganism including, but not limited to, protozoa, algae and fungi;

(2) Is a procaryotic microorganism, including, but not limited to, Eubacteria and Archaebacteria; or

(3) Is a parasitically replicating microscopic element, including, but not limited to, viruses.

Microbial pesticides resulting from rearrangements means a microbial pesticide resulting from translocations or inversions of genetic material.

Microorganism means a bacterium, fungus, alga, virus, or protozoan.

Nonindigenous microbial pesticide means a microbial pesticide brought into one of the following geographic areas from outside that area:

(1) The continental United States, including Alaska, and the immediately adjoining countries (i.e., Canada and Mexico).

(2) The Hawaiian Islands.

(3) The Caribbean Islands including Puerto Rico and the U.S. Virgin Islands.

Pesticidal property means a characteristic exhibited by a microorganism that contributes to the intentional use of the microorganism to prevent, destroy, repel, or mitigate a pest or to act as a plant regulator, defoliant, or desiccant.

Single genome means the sum total of chromosomal and extrachromosomal genetic material of an isolate and any descendants derived under axenic culture conditions from that isolate.

Small-scale test means the experimental use of a microbial pesticide in a facility such as a laboratory or greenhouse, or use in limited replicated field trials or other tests as described in § 172.3(c).

Test or testing means any use of a microbial pesticide consistent with section 5 of the Act, including limited replicated field trials and associated activities.

Translocations of genetic material means a chromosomal configuration in which part of a chromosome becomes attached to a different chromosome, or inserts in a different location on the same chromosome.

(a) Who must submit a Notification. Notwithstanding § 172.3, any person who plans to conduct small-scale testing of a type of microbial pesticide identified in paragraph (c) of this section must submit a Notification to EPA and obtain prior approval for either of the following tests:

(1) Small-scale tests that involve an intentional environmental introduction of that microbial pesticide.

(2) Small-scale tests performed in a facility without adequate containment and inactivation controls as provided in paragraph (e) of this section.

(b) Alternative to Notification. In lieu of a Notification, any person required to submit a Notification under paragraph (a) of this section may submit an application for an experimental use permit (EUP) to EPA for approval.

(c) Small-scale testing that requires a Notification. As provided in paragraph (a) of this section, and notwithstanding any other approval by any governmental entity, EPA review and approval are required prior to the initiation of any small-scale test involving either of the following microbial pesticides:

(1) Microbial pesticides whose pesticidal properties have been imparted or enhanced by the introduction of genetic material that has been deliberately modified.

(2) Nonindigenous microbial pesticides that have not been acted upon by the U.S. Department of Agriculture (i.e., either by issuing or denying a permit or determining that a permit is unnecessary; or a permit is not pending with the USDA).

(d) Small-scale testing that does not require a Notification. (1) Testing conducted with microbial pesticides identified in paragraph (c) of this section, but made exempt pursuant to § 172.52, does not require a Notification. The following microbial pesticides (or classes of pesticides) are exempt from the notification requirement in paragraph (a) of this section:

(i) Microbial pesticides resulting from deletions or rearrangements within a single genome that are brought about by the introduction of genetic material that has been deliberately modified.

(ii) [Reserved]

(2) Testing conducted in a facility with adequate containment and inactivation controls, as provided in paragraph (e) of this section, does not require a Notification.

(e) Selection and use of containment and inactivation controls. (1) Selection and use of containment and inactivation controls for a particular microbial pesticide shall take into account the following:

(i) Factors relevant to the microbial pesticide'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.

(iv) Plans for routine or emergency clean-up and test termination.

(2) For purposes of paragraph (e)(1) of this section, EPA will presume that compliance with the containment provisions of the National Institutes of Health (NIH) “Guidelines for Research Involving Recombinant DNA Molecules” (51 FR 16958, May 7, 1986) constitutes selection and use of adequate containment and inactivation controls.

(3) The selection of containment and inactivation controls shall be approved by an authorized official of the organization that is conducting the test prior to commencement of the test.

(4) Records shall be developed and maintained describing the selection and use of the containment and inactivation controls, including contingency plans for emergency clean-up and test termination, that will be used during the test. These records shall be available for inspection at the test facility. In addition, these records shall be submitted to EPA at EPA's request and within the time frame specified in EPA's request.

(5) Subsequent to any EPA review of the containment/inactivation controls selected under paragraph (e)(1) of this section, changes to the controls necessary to prevent unreasonable adverse effects must be made upon EPA request. Failure to comply with EPA's request shall result in automatic revocation of the exemption from the requirement to submit a Notification.

(a) When to submit a Notification. A Notification shall be submitted for approval at least 90 days prior to the initiation of the proposed test.

(b) Where to submit a notification. A notification shall be submitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b), Attention: Biotechnology Notification Review.

(c) How to format a Notification. A Notification submitted under this section must comply with the following procedures, but is not required to comply with the format and other provisions governing submission of data in §§ 158.32 and 158.33 or §§ 161.32 and 161.33 of this chapter. However, because data submitted with the Notification may subsequently be used to support other regulatory actions (e.g., used in EUP or registration applications), it is recommended that such data comply with EPA requirements in §§ 158.32 and 158.33 of this chapter.

(1) Each Notification must be accompanied by a transmittal document that clearly identifies the EPA action supported as a Biotechnology Notification Review.

(2) Five copies of each Notification must be submitted to EPA.

(3) Any claims of confidentiality for information submitted in the Notification must be made as described in paragraph (d) of this section.

(d) How to make confidential business information (CBI) claims in a Notification. Although it is strongly recommended that the submitter minimize the amount of data and other information claimed as CBI, a submitter may assert a claim of confidentiality for all or part of the information submitted to EPA in a Notification (See part 2, subpart B of this chapter). To assert such a claim, the submitter must comply with the following procedures:

(1) Any claim of confidentiality must accompany the information at the time the information is submitted to EPA. Failure to assert a claim at that time will be considered a waiver of confidentiality for the information submitted, and the information may be made available to the public, subject to section 10(g) of the Act, with no further notice to the submitter.

(2) Of the five copies of the Notification required by paragraph (c) of this section, four copies must be complete with the information that is claimed confidential clearly marked in the manner described in § 2.203(b) of this chapter. All information claimed as confidential must be deleted from the fifth copy, but it must be otherwise complete. The first page of the fifth copy must be marked “Contains no information claimed as confidential.” EPA may include the fifth copy in a public file without further notice. EPA will consider incomplete a Notification containing information claimed as CBI that is not submitted in accordance with this paragraph and will suspend the review period on the Notification until such procedures are followed.

(3) Any claim of confidentiality must be accompanied, at the time the claim is made, by comments substantiating the claim and explaining why the submitter believes that the information should not be disclosed. The submitter should refer to § 2.204(e)(4) of this chapter for points to address in the substantiation. If such comments are themselves claimed confidential and are marked confidential when submitted to EPA, they will be treated as such in accordance with § 2.205(c) of this chapter. EPA will consider incomplete all Notifications containing information claimed as CBI that are not accompanied by substantiation, and will suspend the review period on such Notifications until the required substantiation is provided.

(4) EPA will disclose information that is subject to a claim of confidentiality asserted under this section only to the extent and by means of the procedures set forth in section 10 of the Act, in this subpart, and in part 2 of this chapter.

This section identifies the data and information to be included in each Notification. When specific information is not submitted, an explanation of why it is not practical or necessary to provide the information is to be provided.

(a) The identity of the microorganism which constitutes the microbial pesticide including:

(1) Summary of data supporting the taxonomic designation and its interpretation.

(2) Means and limit of detection using sensitive and specific methods (e.g., note the use of any markers that are used to distinguish the introduced population from native microorganisms). Introduction into the microbial pesticide of a unique genetic marker is encouraged.

(b) Description of the natural habitat of the parental strain of the microbial pesticide including information on:

(1) Physical and chemical features important to growth and survival of the parental strain.

(2) Biological features of the parental strain that would have an impact on the microbial pesticide (e.g., presence of phages that infect the microorganism).

(3) Competitors.

(c) Information on the host range of the microbial pesticide, if any, with an assessment of infectivity and pathogenicity to nontarget organisms.

(d) Information on survival and the ability of the microbial pesticide to increase in numbers (biomass) in the environment (e.g., in the environment into which the microbial pesticide will be introduced, and in substantially different environments that may be in the immediate vicinity). These data may be derived from the scientific literature or from tests conducted in a laboratory or other containment facility.

(e) The identity of possible transmission vectors (e.g., insects).

(f) Data on relative environmental competitiveness compared to the parental strain of the microbial pesticide.

(g) Description of the methods used to genetically modify the microbial pesticide.

(h) The identity and location of the gene segments that have been rearranged or inserted/deleted (host source, nature, and, for example, base sequence data, or restriction enzyme map of the genes).

(i) Information on the control region of the genes, and a description of the new traits or characteristics that are expressed.

(j) Data on potential for genetic transfer and exchange with other organisms and on genetic stability of any inserted sequences in the microbial pesticide.

(k) A description of the proposed testing program including:

(1) The purpose or objectives of the proposed testing.

(2) Designation of the pest organisms involved (common and scientific names).

(3) The States in which the proposed program will be conducted.

(4) The exact location of the test sites (including proximity to residences and human activities, surface water, etc.).

(5) The crops, fauna, flora, geographical description of sites, modes, dosage rates, frequency, and situation of application on or in which the pesticide is to be used.

(6) The total amount of pesticide product proposed for use in the testing.

(7) The method of application.

(8) A comparison of the natural habitat of the microbial pesticide with the proposed test site.

(9) The number of acres, structural sites, or animals/plants by State, to be treated or included in the area of experimental use.

(10) Procedures to be used to protect the test area from intrusion by unauthorized individuals.

(11) The proposed dates or periods during which the testing program is to be conducted, and the manner in which supervision of the program will be accomplished.

(12) Description of procedures for monitoring the microbial pesticide within and adjacent to the test site during the test.

(13) The method of sanitation or disposal of plants, animals, soils, farm tools, machinery etc., that will be exposed to the microbial pesticide during or after the test.

(14) Means of evaluating potential adverse effects and methods of controlling the microbial pesticide if detected beyond the test area.

(l) A statement of composition for the formulation to be tested, giving:

(1) The name and percentage by weight (or other suitable units) of each ingredient, active and inert.

(2) Production methods.

(3) Extraneous microorganisms present as contaminants.

(4) Amount and potency of any toxin present.

(5) Where applicable, the number of viable microorganisms per unit weight or volume of the product or other appropriate system for designating the quantity of active ingredient.

(m) Any additional factual information regarding the potential for unreasonable adverse effects on the environment.

(a) EPA will review and evaluate each Notification as expeditiously as possible and will make a determination no later than 90 days after receipt of the complete Notification; however, under no circumstances shall the proposed test proceed until the submitter has received notice from EPA of its approval of such test.

(b) For each Notification, EPA may make the following determinations:

(1) Require additional information from the submitter to assess the proposed test adequately.

(2) Approve the proposed test.

(3) Approve the proposed test provided that the submitter makes certain modifications to the test proposal.

(4) Require an EUP for the test.

(5) Disapprove the proposed test because of the potential for unreasonable adverse effects. Such disapproval by EPA shall be considered the equivalent of denial of an EUP and the remedies for such denial provided by § 172.10 are available to the submitter.

(c) If the proposed test is approved by EPA, then the submitter shall perform the test in the same manner described in the Notification, subject to any requirements imposed under paragraph (b)(3) of this section.

(a) Initiation of the exemption process. Pesticides may be added to the list of exemptions in § 172.45(d) by rule at EPA's initiative or in response to a petition submitted in accordance with paragraph (b) of this section.

(b) Petitions for exemption from the requirement for a Notification—(1) Who may submit a petition. Any person may submit a petition requesting an exemption from the notification requirements of this subpart for a specific microbial pesticide or class of microbial pesticides.

(2) Where to submit a petition. All petitions shall be submitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).

(3) Content of petition. Each petition shall contain the following:

(i) Name and address of petitioner and name, address, and telephone number of a person who may be contacted for further information.

(ii) Description of the exemption requested, including the specific microbial pesticide or class of microbial pesticides to be tested under the petition for exemption.

(iii) Basis for the petitioner's contention that the specific microbial pesticide or class of microbial pesticides meet the criteria of § 172.3 for small-scale tests of pesticides that do not require an EUP.

(iv) Discussion of the extent to which the microbial pesticide or class of microbial pesticides covered by the petition differ from microbial pesticides that are already registered or subject to an EUP under the Act.

(4) Administrative action on a petition. EPA will review and evaluate petitions as expeditiously as possible and may request further information from the petitioner to assess the proposed exemption adequately. No later than 180 days after the submission of a petition, or 90 days after the last submission of additional information by the petitioner, whichever is later, EPA will take one of the following actions with respect to the petition:

(i) Grant the petition and publish a notice of proposed rulemaking in the Federal Register for a 45-day comment period proposing the exemption requested by the petitioner.

(ii) Grant the petition and publish a notice of proposed rulemaking in the Federal Register for a 45-day comment period proposing an exemption under such terms and conditions as EPA deems appropriate.

(iii) Deny the petition and provide the petitioner with a written explanation of EPA's decision.

(5) Confidential business information (CBI) claims. To assert a claim of confidentiality, the petitioner must comply with the applicable procedures in § 172.46(d).

(6) Supplements, amendments, and withdrawals. The petitioner may supplement, amend, or withdraw his or her petition in writing without EPA approval at any time prior to the granting or denial of the petition under paragraph (b)(4) of this section. The withdrawal of a petition shall be without prejudice to the resubmission of the petition at a later date.

Any person using a microbial pesticide in small-scale testing covered by this subpart who obtains information regarding potential unreasonable adverse effects on health or the environment must within 30 days of receipt of such information submit the information to EPA, unless the person has actual knowledge that EPA has been adequately informed of such information. The requirement to submit information applies both to those microbial pesticides subject to the notification requirements under § 172.45(c) and those that are exempt under § 172.45(d).

(a) Imminent threat of substantial harm to health or the environment. The use of a microbial pesticide in small-scale testing covered by this subpart (whether subject to the notification requirements of § 172.45(c) or exempt under § 172.45(d)) in a manner that creates an imminent threat of substantial harm to health or the environment is prohibited, and is considered a violation of section 12(a)(2)(S) of the Act.

(b) EPA response to violations. Under section 14 of the Act, EPA may seek civil or criminal penalties for violations of the Act. Failure to comply with the regulations in this part could result in civil or criminal penalties. Moreover, under sections 14 and 16(c) of the Act, EPA may at any time take appropriate action against violators to prevent or otherwise restrain use of a microbial pesticide in small-scale testing if it is determined that:

(1) Such use would create an imminent threat of substantial harm to health or the environment that is prohibited under paragraph (a) of this section; or

(2) The terms or conditions on which approval of the testing was granted under this subpart C are violated.