Plant Incorporated Protectants
Curent as of January 2015
On This Page
- History of Regulating PIPs
- Regulations
- Science Issues - updated January 2015
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.
- Current & Previously Registered Section 3 PIP Registrations
- Helpful Hints for Experimental Use Permits
History of Regulating PIPs
- Biotech Information-Sharing MOU to Enhance Federal Agency Coordination - February 1, 2012 (7 pp, 1.8 M, about PDF)
- Scientific Advisory Panel Meetings on Issues Regarding PIPs (External Peer Review)
- Starlink ™ Corn Regulatory Information [Starlink (Cry9C) Bt Corn ]
- Event 176 Bt Corn and the Monarch Issue (PDF): (8 pp, 275K, about PDF) 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 (August 22, 2001)
- October 2001 Reassessment of Bt PIPs for Corn, Cotton, and Potato Biopesticides Registration Action Document- Bacillus thuringiensis Plant-Incorporated Protectants.
- BT 10 corn issues U.S. Environmental Protection Agency's Statement on Bt10
- Overview of EPA's Regulation of Bacillus thuringiensis (Bt) Crops (May 2002) This paper provides specific information regarding the regulation of Bt crops including refuge information, Monarch butterfly risks, and Starlink corn
- Agency Response to Greepeace International et al. April 19, 2000 (PDF) (455 pp, 122 K, about PDF)
Regulations
- Federal Register Notice (July 19, 2001) Regulations Under the Federal Insecticide, Fungicide, and Rodenticide Act for Plant-Incorporated Protectants (Formerly Plant- Pesticides)
- Federal Register Notice (July 19, 2001) 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 (Formerly Plant-Pesticides)
- Federal Register Notice (July 19, 2001) 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 (Formerly Plant-Pesticides)
- Federal Register Notice (Oct 11, 2006) Plant-Incorporated Protectants Derived from a Plant Viral Coat Protein Gene (PVCP-PIPs); Notification to the Secretary of Agriculture
- Federal Register Notice (Sept. 29, 2006) Draft Guidance for Pesticide Registrants on Small- Scale Field Testing and Low-level Intermittent Presence in Food of Plant-Incorporated Protectants (PIPs) (See regulations.gov, "Advance Search" for Docket ID ID EPA-HQ-OPP-2006-0291)
- Federal Register Notice: (April 4, 2007) Plant-Incorporated Protectants; Potential Revisions to Current Production Regulations
- Federal Register Notice (April 18, 2007) Exemption under FIFRA for Certain Plant-Incorporated Protectants Derived from Plant Viral Coat Protein Gene(s) (PVCP-PIPs)
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Federal Register Notice (April 18, 2007) Exemption from the Requirement of a Tolerance under FFDCA for Residues of Plant Virus Coat Proteins that are part of a Plant-Incorporated Protectant (PVC-Proteins)
- Exemption proposals for plant-incorporated protectants based on plant virus coat protein genes (PVCP-PIPs)
Science Issues
- Insect Resistance Management
- January 28, 2015, Announcement - EPA Proposes Framework to Improve Corn Rootworm Resistance
- December 4-6, 2013, SAP Meeting: Scientific Uncertainties Associated with Corn Rootworm Resistance Monitoring for Bt corn Plant Incorporated Protectants (PIPs)
- October 11, 2012, Cry3Bb1 Insect Resistance Management Team Review
- Insect Resistance Management General Docket
- Key Human Health Assessments
- BT 10 corn issues U.S. Environmental Protection Agency's Statement on Bt10
- Starlink ™ Corn Regulatory Information [Starlink (Cry9C) Bt Corn ]
- Key Environmental Assessments
- Non-Target Organism Data Requirements SAP Meeting on Characterization and non-Target Organism Data Requirements for Protein Plant-Pesticides held on Dec 8-9, 1999. Background (PDF) (23 pp, 77 K, about PDF) Final SAP Report (PDF) (47 pp, 146 K, about PDF)
- Event 176 Bt Corn and the Monarch Issue. 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 (PDF) (8 pp, 275 K, about PDF) is available (August 22, 2001)
- Resources