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Pesticide Registration Manual:
Chapter 3 - Additional Considerations for Biopesticide Products

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Current as of July 2010

In this Chapter:

Additional Considerations for Biopesticide Products

Biopesticides are a type of pesticide derived from such natural materials as animals, plants, bacteria, and certain minerals. For example, canola oil and baking soda have pesticidal applications and are considered biopesticides. Biopesticides fall into three major classes: microbial pesticides, plant-incorporated protectants, and biochemical pesticides. 

A separate chapter on biopesticides is included in this manual because there are different requirements for biopesticides that need to be explained in detail.  This chapter should be referred to in conjunction with Chapter 2, “Registering a Pesticide Product.”

Microbial pesticides are microorganisms that produce a pesticidal effect that are:

  1. eukaryotic microorganisms including, but not limited to, protozoa, algae, and fungi;
  2. prokaryotic microorganisms, including, but not limited to, bacteria; or
  3. autonomous replicating microscopic elements, including, but not limited to, viruses.

Microbial pesticides can control many different kinds of pests, although each separate active ingredient is relatively specific for its target pest(s). For example, there are fungi that control certain weeds and other fungi that kill specific insects.

The most widely used microbial pesticides are subspecies and strains of Bacillus thuringiensis, or Bt. Each strain of this bacterium produces a different mix of proteins, and specifically kills one or a few related species of insect larvae. While some Bt strains control moth larvae found on plants, others are specific for larvae of flies and mosquitoes. The target insect species are determined by whether the particular Bt produces a protein that can bind to a larval gut receptor, thereby causing the insect larvae to starve.

Plant-Incorporated-Protectants (PIPs) are pesticidal substances that plants produce and the genetic material that has been added to the plant. For example, scientists can take the gene for the Bt pesticidal protein and introduce the gene into the plant's own genetic material. Then the plant, instead of the Bt bacterium, manufactures the substance that destroys the pest. EPA regulates the protein and its genetic material, but not the plant itself.

Biochemical pesticides are pesticidal substances that:

  1. are naturally occurring chemicals or are synthetically derived equivalents;
  2. have a history of exposure to humans and the environment demonstrating minimal toxicity, or in the case of synthetically derived biochemical pesticides, are equivalent to a naturally occurring chemical that has such a history; and
  3. have a nontoxic mode of action to the target pest(s).

Biochemical pesticides include, but are not limited to:

  1. semiochemicals (insect pheromones and kairomones),
  2. natural plant and insect regulators,
  3. naturally occurring repellents and attractants, and
  4. enzymes.

Biochemical pesticides include substances, such as insect sex pheromones, which interfere with mating, as well as various scented plant extracts that attract insect pests to traps. Because it is sometimes difficult to determine whether a substance meets the criteria for classification as a biochemical pesticide, EPA has established the Biochemical Classification Committee to make such decisions. The chair of the Committee is Russell Jones.

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Products Exempt from Registration

EPA has determined that pest control organisms such as insect predators, nematodes, and macroscopic parasites are exempt from the requirements of FIFRA (40 CFR 152.20(a) (PDF) (1 pp, 143.30 k About PDF) ). 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 ingredients are not subject to regulation under FIFRA (40 CFR 152.25(b)) (PDF) (1 pp, 149.25 k About PDF).

Note: The use of pheromones in traps in conjunction with conventional pesticides, or in other application methods (other than traps), is subject to regulation under FIFRA.

Minimum risk pesticides that meet certain criteria are a special class of pesticides that are not subject to federal registration requirements because their ingredients, both active and inert, are demonstrably safe for the intended use. They are exempt from federal registration under section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA does not review or register pesticides that satisfy the 25(b) criteria (PR Notice 2000-6) (PDF) (11 pp, 534k), though registration is required by most states. Read more about products exempt from registration.

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Registration Package for Biochemical and Microbial Pesticides

The application categories described in Chapter 2 apply to all applications for registration of conventional, biopesticide, and antimicrobial pesticide products. All applications for registration must include the data, information, forms, and fees and/or fee waiver or exemption requests as described in Chapter 2.

Biochemical and microbial pesticides are, however, subject to a different set of data requirements for registration than conventional chemicals, and are listed in Data Requirements for Registration 40 CFR Part 158:

EPA has published guidance for developing these data in the Biochemical Pesticides Test Guidelines, OPPTS Series 880 and the Microbial Pesticides Test Guidelines, OPPTS Series 885. Please also refer to Chapter 2 of this manual for general information on submitting an application for registration, and to Chapter 12 for additional information concerning experimental use permits.

Several helpful tips are available on the Web page for biopesticides, specifically the Biopesticide Registration Tools Web page, to aid applicants in preparing biopesticide submissions. Among these are:

  1. how to avoid Confidential Statement of Formula or product chemistry issues with biopesticide submissions, and
  2. examples of BPPD internal application checklists for amendment and registration application review.

Genetically modified microbial pesticides may be subject to additional (or fewer) data requirements or information requirements on a case-by-case basis, depending on the particular microorganism, the parent microorganism, the proposed use pattern, and the manner and extent to which the organism has been genetically modified.

Additional data requirements may include:

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BPPD PRIA Review Phases

The Biopesticides and Pollution Prevention Division (BPPD) has grouped its review of Pesticide Registration Improvement Renewal Act (PRIA 2) actions into five phases.

If the application’s information is found to be deficient after the 21-day initial content screen, the applicant is notified in writing of the deficiencies per 40 CFR 152.105 (PDF) (1 pp, 132.00 k About PDF) and allowed 75 days to make the corrections or additions to complete the application. If after 75 days, the applicant has not responded or failed to complete the application, the Agency will terminate further action and treat the application as if withdrawn. In this case, the completed application will have to be resubmitted and treated as a new application. If the applicant believes that the deficiencies cannot be corrected within 75 days, it must notify the Agency within those 75 days of the date on which it expects to complete the application. For registration applications that fall under the Pesticide Registration Improvement Act (PRIA), the Agency has timeframes in which decisions need to be made on the applications. Application deficiencies may require that the timeframe be extended, and Chapter 5’s section on Negotiated Due Date Extensions describes the process for extending due dates. The Phase at which a deficiency is identified influences the new due date proposed.

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Regulation of Plant-Incorporated Protectants

Consistent with the Coordinated Framework for Regulation of Biotechnology issued by the U.S. Office of Science and Technology Policy in 1986 (51 FR 23302) genetically modified (GM) crops with pesticidal traits fall under the oversight of EPA, the U.S. Department of Agriculture, and the U.S. Food and Drug Administration.

EPA’s oversight focuses on the pesticidal substance produced (e.g., Bt Cry proteins) and the genetic material necessary for its production in the plant (e.g., cry genes). EPA calls this unique class of biotechnology-based pesticides plant-incorporated protectants (PIPs) and describes procedures specific for PIPs in Procedures and Requirements for Plant-Incorporated Protectants (40 CFR Part 174 (PDF) (1 pp, 143.32 k About PDF)). Read helpful tips regarding experimental programs for PIPs. Further guidance on small-scale field testing of PIPs and low-level presence in food is listed in PR Notice 2007-2.

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Pheromone Regulatory Relief

The Agency acknowledges that use of certain types of pheromone products presents lower risk than conventional pesticides, and also acknowledges the unique properties of these niche-type products regarding their inherently narrow host range. To promote the use of pheromone products, the Agency initiated a regulatory relief program that allows flexible confidential statements of formula for pheromone experimental use permits (EUPs) to allow for active ingredient adjustments during the course of experimentation. The Agency has also published generic tolerances and relaxed the acreage cut-off when an EUP is required.  Refer to Chapter 12 on EUPs.

EPA established the following special regulations as a result of the pheromone regulatory relief program:

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Data Portion

The data portion of a registration amendment that requires product-specific data may include the following items, as applicable:

Please note that efficacy data for nonpublic-health uses must be conducted and maintained on file by the registrant, although these data are not generally required to be submitted for review.

Important Note: When submitting data, three copies are required, properly bound and formatted in accordance with PR Notice 86‑5.  Refer to Chapter 15 for additional information on submitting data.

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Small-Scale Field Test Notifications for Certain Genetically Modified Microbial Pesticides

Notification and Reporting Requirements

Applicants must submit a notification to EPA to obtain approval before starting small-scale testing of certain genetically modified microbial pesticides or non-indigenous microbial pesticides that USDA has not previously acted upon. This approval covers intentional introduction into the environment or small-scale testing in a facility that lacks adequate containment and inactivation controls (40 CFR 172.45 (PDF) (2 pp, 146.43 k About PDF)).

The Notification should be submitted to EPA for approval at least 90 days prior to the initiation of the proposed test (40 CFR 172.46 (PDF) (2 pp, 146.29 k About PDF)).

Mail the Notification as described in Chapter 21.

EPA will review and evaluate each Notification as quickly 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.

Before making a final determination, the Agency may

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Petition for Exemption from Notification Requirements

A petition for exemption from the notification requirements for a specific microbial pesticide or class of microbial pesticides may be submitted to the Biopesticides and Pollution Prevention Division. EPA will review and evaluate petitions as expeditiously as possible (no later than 180 days after the submission or 90 days after the last submission of additional information, whichever is later), and may request further information from the petitioner to assess the proposed exemption adequately. EPA will

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Substitution of an EUP Application for a Notification

In lieu of a Notification, an application for an EUP may be submitted to EPA for approval.

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Contacts for Additional Information

For contact information, refer to the Organizational Charts in Chapter 21 or to the Biopesticides Web page.

BPPD Consistency

The bppdconsistency (bppdconsistency@epa.gov) e-mail address has been created to respond to issues concerning biopesticide registration inconsistencies that affect submission processing. Biopesticide Regulatory Action Leaders (RALs) meet to discuss issues sent to the “bppdconsistency” e-mail address and the resolution is posted to the Biopesticide Registration Inconsistency Issues Web page.

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References Cited in Chapter 3

Refer to Chapter 19 for information on the source of these documents.

Code of Federal Regulation, Title 40

Harmonized Test Guidelines

Pesticide Registration Notices (PR Notices)

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