CHAPTER 3 - CONSIDERATIONS FOR REGISTRATION OF A BIOCHEMICAL OR A MICROBIAL PESTICIDE A. GENERAL INFORMATION The following discussion and information is a general overview of the Agency's policies and regulations as they relate to biochemical and microbial pesticides. Biochemical and microbial pesticides are generally distinguished from conventional chemical pesticides by their unique modes of action, target species specificity, and natural occurrence. In addition, low use volumes microbial pesticides may be capable of growth and reproduction in the environment or in suitable hosts (40 CFR 158.65). Both naturally occurring and genetically modified microorganisms are included in the microbial pesticide group. Although the administrative contents of an application for registration of a biochemical or microbial pesticide are the same as a conventional chemical pesticide, biochemical and microbial pesticides are subject to a different (generally reduced) set of data requirements as specified in 40 CFR 158.690 and 158.740. The Agency has published guidance for developing these data in the Pesticide Assessment Guidelines, Subdivision M, Microbial and Biochemical Pest Control Agents (see Chapter 16 of this manual for a source.) You should also refer to Chapter 2 for general information on submitting an application for registration, and to Chapter 9 for additional information concerning experimental use permits. The Agency's policies and requirements concerning the notification and reporting requirements for small-scale field tests and the experimental use permit and registration requirements for microbial pesticides under FIFRA were discussed in detail in the Federal Register Notice of June 26, 1986 (51 FR 23313). The Federal Register Notice of June 26, 1986, and the 40 CFR citations provided throughout this chapter should be referred to for detailed information on these policies and regulations. IMPORTANT NOTE: The Agency is developing a separate registration guidance document specifically for biochemical and microbial pesticides that may be available by the time you receive this manual. It is recommended that you contact the appropriate Product Manager (see section F.) for this document and for additional guidance prior to initiating testing, or filing an application for registration of a biochemical or microbial pesticide. IMPORTANT NOTE: Once you have obtained the data from your EUP, follow the procedures in Chapter 2 of this manual when filing an application for registration of a biochemical or microbial pesticide. B. PRODUCTS EXEMPT FROM REGISTRATION The Agency has determined that pest control organisms such as insect predators, nematodes, and macroscopic parasites are exempt from the requirements of FIFRA [(see 40 CFR 152.20(a). In addition, pheromones and identical or substantially similar compounds labeled for use only in pheromone traps and pheromone traps in which those chemicals are the sole active ingredient are not subject to regulation under FIFRA [(40 CFR 152.25(b)]. IMPORTANT NOTE: The use of pheromones in traps in conjunction with conventional pesticides, or in other application methods (other than traps) are subject to regulation under FIFRA. C. BIOCHEMICAL PESTICIDES Biochemical pesticides include, but are not limited to, products such as semiochemicals (e.g., insect pheromones), hormones (e.g., insect juvenile growth hormones), natural plant and insect growth regulators, and enzymes. When necessary, the Agency will evaluate products on an individual basis to determine whether they are biochemical or conventional pesticides. D. MICROBIAL PESTICIDES Microbial pesticides are microorganisms and include but are not limited to bacteria, algae, fungi, viruses, and protozoa used as pest control agents (40 CFR 152.20). The data requirements in 40 CFR 158.740 apply to all microbial pesticides, including those that are naturally-occurring as well as those that are genetically modified. Each "new" variety, subspecies, or strain of an already registered microbial pest control agent must be evaluated, and may be subject to additional data requirements. Genetically modified or non-indigenous microbial pesticides may be subject to additional (or lesser) data requirements or information requirements on a case-by-case basis depending on the particular microorganism, its parent microorganism, the proposed use pattern, and the manner and extent to which the organism has been genetically modified. Additional requirements may include information on the genetic engineering techniques used, the identity of the inserted or deleted gene segment (base sequence data or enzyme restriction map of the gene), information on the control region of the gene in question, a description of the "new" traits or characteristics that are intended to be expressed, tests to evaluate genetic stability and exchange, and/or selected Tier II environmental expression and toxicology tests. E. SMALL-SCALE FIELD TESTING LEVEL I REPORTING AND LEVEL II NOTIFICATION REQUIREMENTS The information provided below is a general overview of the small-scale field testing requirements for microbial pesticides as described in the June 26, 1986 Federal Register Notice (51 FR 23313). It is also recommended that you contact the appropriate Product Manager listed at the end of this Chapter to determine current policies concerning testing and registration requirements for microbial pesticides, since these policies and requirements are currently being revised. Small-scale field studies are (1) terrestrial field studies that involve 10 acres or less of land; and (2) aquatic field studies that involve 1 surface-acre or less of water. 1. Level I reporting - Level I reporting for small- scale field testing applies to all genetically engineered or non-indigenous microbial pesticides not otherwise covered by Level II notification. Detailed information on the reporting requirements is contained in the June 26, 1986, Federal Register Notice (51 FR 23303). The Agency will have up to 30 days to review the above information reported to make a preliminary determination of the need for an experimental use permit (EUP). If, on preliminary assessment, the test raises sufficient concerns such that the Agency determines that additional information or monitoring is warranted (e.g., microorganisms for which there is limited scientific information or regulatory experience, or that warrant specific environmental monitoring during the test), then an EUP will be required. In this case, the applicant has two options: 1) the applicant may apply for a permit providing the necessary data and information required to support the application, or 2) the applicant may provide all additional data and information required under Level II notification. If the latter option is chosen, the Agency will review the full notification package and make a determination as to whether an EUP is required. IMPORTANT NOTE: Since most microbial pesticides are at least toxic to the target organism, and therefore are "pathogens", they cannot be considered under Level I but must instead be submitted under Level II. 2. Level II notification - Level II notification for small- scale field testing applies to microbial pesticides: Microbial pesticides formed by deliberately combining genetic material from organisms of different genera, genetically engineered microbial pesticides derived from source organisms that are pathogens, and non-indigenous pathogenic microbial pesticides. A pathogen is defined as an organism that has the ability to cause disease in other living organisms (i.e., humans, animals, plants, or microorganisms). Notification should include adequate background information on the microorganism, and description of the proposed test. Detailed information of the notification requirements is contained in the June 26, 1986, Federal Register Notice (51 FR 23303). The Agency encourages prospective applicants to meet with the EPA prior to submission of their notification to discuss their field test and to determine what specific data would be necessary to evaluate the product. Once the supporting data have been submitted, the Agency has up to 90 days to review each Level II notification and determine if an EUP is required. F. WHO TO CONTACT FOR ADDITIONAL INFORMATION If you have any questions or require any additional information concerning biochemical or microbial pesticides, contact Product Manager 18 for insecticide products or Product Manager 21 for herbicide or fungicide products. A listing of Product Managers may be found in Chapter 18. G. REFERENCES CITED IN CHAPTER 3 - Refer to Chapter 16 for information on the source of these documents. 1. Code of Federal Regulations, Title 40 Part 152 - Pesticide registration and classification procedures Part 158 - Data requirements for registration 2. Federal Register Notice, June 26, 1986 (51 FR 23303) 3. Pesticide Assessment Guidelines, Subdivision M, Microbial and Biochemical Pest Control Agents, October 1982, (EPA No. 540/09-82-028) Environmental Protection Agency IMPORTANT NOTE: The Agency is currently revising the Subdivision M Guidelines. The draft document dated March, 1989 is available from the Public Docket and Freedom of Information Section, Field Operations Division. See Chapter 18 of this manual for a contact point.