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.

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 against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of plant-incorporated protectants, including acute reactions, such as toxicity, allergenicity, and skin and eye irritation, as well as long-term effects including cancer, birth defects, and reproductive and neurological system disorders. Our scientists also evaluated these potential effects in light of the public’s potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person would be exposed at levels that would pose a health risk. Based on our reviews of the scientific studies and often 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.

Currently Registered Section 3 PIP Registrations

Current Plant Incorporated Protectant (PIP) Experimental Use Permits

The October 2001 Biopesticides Registration Action Document- Bacillus thuringiensis Plant-Incorporated Protectants is available online.

EPA's Regulation of Bacillus thuringiensis (Bt) Crops This paper provides specific information regarding the regulation of Bt crops including refuge information, Monarch butterfly risks, and Starlink corn

The Preface and Executive Summary of a Study entitled Amended Revised Response to EPA's Data Call-In Notice Concerning the Potential for Adverse Effects on Non-Target Lepidopterans is available (275k PDF 8pages) (August 22, 2001)

Proceedings of EPA Public Workshop - Plant-Incorporated Protectant Experimental Use Permit: Process and Compliance

- The Bt  Cry1F in corn Fact sheet (006481) (28p PDF 164k)  and the  Bt Cry1F in corn BRAD  (56p PDF 652k)  are now available (8/14/01)
Note: Acrobat^® Reader v5 required to read

- A White Paper (56k PDF) on the possible presence of Cry9C protein in processed human foods made from food fractions produced through the wet milling of corn is available (3/7/01)

-  Plant-Incorporated Protectant Rules Signed:

  - FR: Regulations Under the Federal Insecticide, Fungicide, and Rodenticide Act for Plant-Incorporated Protectants (PDF)

  - FR: Exemption From the Requirement of a Tolerance Under the Federal Food, Drug, and Cosmetic Act for Residues of Nucleic Acids that are Part of Plant-Incorporated Protectants (PDF)

  - FR: Exemption From the Requirement of a Tolerance Under the Federal Food, Drug, and Cosmetic Act for Residues Derived Through Conventional Breeding From Sexually Compatible Plants of Plant-Incorporated Protectants (PDF)

-  Bt Cotton 2001 Refuge Requirements (revised)

-  SAP Meeting on Characterization and non-Target Organism Data Requirements for Protein Plant-Pesticides held on Dec 8-9, 1999.  Background (91 KB, PDF) , Final SAP Report (146 KB PDF) 

StarlinkT Corn Regulatory Archive

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