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Tips for Avoiding Confidential Statement of Formula or Product Chemistry Issues with Biopesticides

Related Information

Current as of March 5, 2007

Below are recommendations that may assist registrants in reducing common mistakes when preparing and submitting biopesticide product chemistry data and the Confidential Statement of Formula (CSF).

On This Page

  1. General Recommendations for registering a biopesticide
  2. Confidential Statement of Formula (CSF) Tips
  3. Product Chemistry Tips
    1. Biochemical Pesticides Tips
    2. Microbial Pest Control Agents (MCPA) Tips
    3. Plant Incorporated Protectants (PIPs) Tips

  1. General Recommendations for Registering a Biopesticide
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  3. Confidential Statement of Formula (CSF) Tips
  4. Refer to the CSF form, EPA Form 8570-4 PDF (2 pp, 1mb , About PDF) and the CSF preparation guide PDF (17 pp, 173 kb About PDF) to prepare biochemical and microbial pesticides CSF’s for submission.

    A CSF preparation guide for plant-incorporated protectants (PIPs) is not available. Registrants for PIPs may also contact the BPPD Microbial Pesticides Branch Chief for details on PIP CSF preparation.

    The CSF preparation guide addresses most CSF issues but additional problems can be avoided by checking the items below:

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  5. Product Chemistry Tips:
  6. Product chemistry guidance is available at Biopesticides Data Tables and Guidelines.

    Even with the available guidance, many submitted packages contain a variety of problematic issues. Avoid delays in registration due to product chemistry. Be sure to:

    1. Biochemical Pesticides Tips
    2. In general, guideline requirements for biochemical pesticides are similar to those of conventional pesticides.

      1. Pheromones and Allelochemicals
      2. Product chemistry is the primary data requirement for pheromones and allelochemicals. The Organization for Economic Co-operation and Development (OECD) Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control PDF (25 pp, 78 kb About PDF) Exit EPA disclaimer provides a good overview of what factors should be considered.

        • data demonstrating allomonal, kairomonal, synomonal, or pheromonal activity
        • straight chain lepidopteran pheromone products should demonste similarity to unbranched aliphatic compounds having 9-18 carbons, up to 3 double bonds, and a terminal alcohol, acetate, or aldehyde functional group
        • information on the size of the carrier bead for formulated products using microencapsulation

      3. Clays, Inorganics and Ash
      4. Registration of inorganic pesticides should consider both solid matrices and potentially soluble components when being described via product chemistry. Matrix product chemistry should include the the percent carbon, the percent crystalline silica and particle size analysis.

        • asbestos fiber quantification is also encouraged for products having vermiculite as a component
        • soluble components such as metals and metalloids shouldt also be described in order to capture the potential for soluble leachates
        • mined or waste ash products are compositionally heterogeneous, so a discussion of mining or production methods that ensure product consistency should be provided

      5. Plant Extracts
      6. Plant extracts are oily heterogeneous mixtures of terpinoid molecules that have been pressed or processed from plants. Submissions should identify the species and variety of the plant. The active components (and/or surrogate analytical markers) in the extract should also be identified, quantified, and have certified limits.

        If the identity of any ingredient or impurity can not be specified as a discrete chemical substance, sufficient information must be provided for EPA review (40 CFR 158.155 (f)). Blending, batch deletion, enrichment with purified components may be used to maintain product consistency. Nominal concentrations will be used for enforcement purposes and must be listed on the product label and CSF. Impurities >0.1% composition should also be identified, quantified, and listed on the CSF (40 CFR 158.155 (d)(1), (2), (3)).

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      7. Peroxides and Oxidative Reaction Products
      8. Peroxide products are characterized by having strong chemical reactivity. Submissions with multiple components should identify secondary byproducts from the reaction and identify the relative component equilibriums in storage over time and at relevant temperatures.

      9. Animal Byproducts
      10. Animal byproducts include such pesticides as urine, blood, and egg solids. Animal byproduct pesticides have the unique potential to transfer viruses, bacteria, fungi, and parasites to humans or other animals. Because of this potential, registrants should submit information regarding the lack of such contaminants.

        Detailed information on the manufacturing process, analytical methods, and quality assurance/quality control (QA/QC) should be provided to demonstrate that the product is free of all potential mammalian pathogens. Justifications for acceptable levels of microbial contaminants and control methods when such levels are exceeded must be included in the QA/QC discussion. These protocols should be submitted to EPA prior to use in a study.

      11. Volatile Compounds
      12. Products with volatile components should provide adequate characterization of the volatile components, including the rate of production in different environmental scenarios, and growth media or chemicals used to produce the volatiles. A discussion of the predicted variability of volatile production is also important to include in product submissions.

      13. Repellents and Attractants in Traps
      14. Products to be dispensed within a trap or dispenser should include a detailed description of the dispensing/trapping device, including anticipated propellents or additional conventional pesticides. Biopesticide submissions conjoined with conventional pesticides should contact the Ombudsman for conventional pesticide products for additional registration information.

      15. Plant and Insect Regulators
      16. Products that are plant or insect regulators should include a discussion of the mechanism of action. The discussion can be supported by data and/or published literature. Activity related to a particular chemical isomer should also be described.

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    3. Microbial Pest Control Agents (MCPA) Tips
    4. In general, MCPAs should be expressed as viable organisms per unit weight or volume (e.g. cfu/g) or international units of potency per unit weight. Methods might need to be combined to verify certified limits and impurities. Consult the specific microbial testing guidelines.

      1. Bacteria, Fungi, Protozoans, Phages and Viruses
      2. Adequate identification of microbes, microbial contaminants, and/or impurities is important for these pesticides. Each microbe should be identified by taxonomic position, serotype, and/or strain utilizing the best methods currently available and have an assigned or nationally recognized collection number (ie Bacillus thuringensis subsp kustaki AA1234; Beauveria bassiana strain 123).

        Alternate names are also important to provide a link to the older literature on the microbe. Identification information should include:

        • the phenotype coded for, and its stability (and rate or exchange with other organisms), and
        • method used to alter the genetics
        • information on the natural occurrence of the microbe, its relationship to other species, and its life cycle and mode of action with respect to target species and known host range.

        A detailed description of the manufacturing process and QA/QC methods should also be submitted. This description must include methods taken to prevent contamination, ensure a uniform product, and identify the MCPA.

        Impurities to describe are:

        • metabolic byproducts,
        • mutant strains
        • microbial contaminants (especially mammalian pathogens or antagonistic microbes),
        • chemical contaminants

        If hazardous contaminants are detected during production or purification, mitigation measures may be proposed in order to ensure that these are present in the final product in non-hazardous quantities. Storage stability should also be submitted to establish expiration dates for the claimed label rates of live microbial active ingredient.

      3. Microbial Products which Produce Volatiles
      4. Microbial products which produce volatile fumigants should fulfill standard microbial guideline requirements for product chemistry. Registrants for these products should also provide adequate characterization of the volatile components, including the rate of production in different environmental scenarios, and growth media (nutrient sources/solid carriers) used to produce the volatiles. A discussion of the predicted variability of volatile production is also important to include in product characterization submissions.

      5. Microbial Consortia or Mixtures and Composted Materials
      6. Microbial consortia and composted material pesticides are inherently difficult to describe using standard product chemistry guidance because of the complexity of components. Contact the Biological and Pollution Prevention Division (BPPD) Microbial Pesticides Branch Chief for further information regarding these types of pesticide products.

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    5. Plant Incorporated Protectants (PIPs) Tips
    6. In general, PIP’s and their associated marker proteins require much of the same CSF information as biochemicals and microbials. For PIPs, however, bulk density, pH, and flash point, (CSF form blocks 7, 8, 9) are typically not applicable (n/a).

      On PIP CSFs, the “Components in Formulation” (block 10) should identify the protein, the genetic material necessary for its production, and the plant into which it was incorporated, since PIPs do not have CAS numbers. Neil Crickmore’s work at the University of Sussex, (UK) provides useful examples of PIP nomenclature Exit EPA disclaimer

      Registrants should express “Each Component in Formulation” (block 13) in terms of plant parts (Whole plant, leaf, root, pollen, seed), in order to provide satisfactory information for Insect Resistance Management and human and ecological risk assessments. Quantitative determinations of the amount of pesticidal protein produced by each plant part should also be presented on a % dry weight basis.

      1. Single Protein PIPs
      2. Product characterization for single protein PIPs has been described in detail at the Science Advisory Panel (SAP) meetings on December 8-9, 1999 and the June 2004

        In general, single protein PIPs should include details of:

        • the inserted DNA
        • transgenic protein production and RNA expression
        • the transformation system
        • the inheritance and stability of functionally induced traits.

        USDA and the Canadian Food Inspection Agency have provided a useful example of molecular and genetic points to consider when characterizing transgenic plants.

      3. Stacked Protein PIPs
      4. Product characterization for multiple or “stacked” protein PIPs should include relevant information on the registered single protein PIP components as well as discussion of any potential antagonistic, synergistic, or potentiating toxicological interactions. Contact the Biological and Pollution Prevention Division (BPPD) Microbial Pesticides Branch Chief more details.

      5. Plant Virus Coat Protein (PVCP) PIPs
      6. These products include PIPs whose inserted genetic material is derived from a plant virus sequence encoding a coat protein. Informational requirements for PVCP registration are currently being determined. Contact the Biological and Pollution Prevention Division (BPPD) Microbial Pesticides Branch Chief for more details.

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