Overview of Plant Incorporated Protectants

Plant-incorporated protectants are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. For example, scientists can take the gene for a specific Bt pesticidal protein and introduce the gene into the plant's genetic material. Then the plant manufactures the pesticidal protein that controls the pest when it feeds on the plant. Both the protein and its genetic material are regulated by EPA; the plant itself is not regulated.

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Overview of PIP Regulation

Before EPA can register a pesticide there must be sufficient data demonstrating that it will not pose unreasonable risks to human health or the environment when used according to label directions. When assessing the potential risks of genetically engineered plant-incorporated protectants, EPA requires extensive studies examining numerous factors, such as:

  • risks to human health, nontarget organisms and the environment;
  • potential for gene flow; and
  • the need for insect resistance management plans.

In regulating PIPs, we base our decisions on strict scientific standards and extensive input from academia, industry, other federal agencies and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested to ensure they meet federal safety standards before they were used on human food and livestock feed crops. See How the Federal Government Regulates Biotech Plants.

EPA scientists assess a wide variety of potential effects associated with the use of plant-incorporated protectants. Based on our reviews of the scientific studies and, in many cases, peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.

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Insect Resistance Management

History of Regulating PIPs

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Risk Assessment for PIPs

Scientific Advisory Panel Meetings on Issues Related to PIPs (External Peer Review)

This subject was discussed at the following meetings.

On the FIFRA Scientific Advisory Panel website:

 In the docket (www.regulations.gov):

In EPA's Web archive: Search EPA Archive

  • June 6-9, 2000: Consultation: National Drinking Water Survey Design for Assessing Chronic Exposure; Mammalian Toxicity Assessment Guidelines for Protein Plant Pesticides
  • February 29-March 3, 2000: Food Allergenicity of Cry9C Endotoxin and Other Non-digestible Proteins; Dietary Exposure Evaluation Model (DEEM) and MaxLIP (Maximum Likelihood Imputation Procedure); Pesticide Residue Decompositing Procedures and Softwares; Dietary Exposure Evaluation Model (DEEM) Consultation on Development and Use of Distributions of Pesticide Concentrations In Drinking Water for FQPA Assessments
  • December 8-9, 1999: Characterization and Non-Target Organism Requirement for Protein Plant Pesticide and Cumulative Risk Assessment Methodology Issues of Pesticide Substances that have a Common Mechanism of Toxicity
  • February 1998: Final Report of the Subpanel on Bacillus thuringiensis (Bt) Plant-Pesticides and Resistance Management

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