Plant Incorporated Protectants

Resources

January 28, 2015 - EPA proposes framework to reduce corn rootworm resistance. Comment period open until 3/16/15 in docket EPA-HQ-OPP-2014-0805 at www.regulations.gov

Learn more about proposed measures to prevent corn rootworm resistance.

Curent as of January 2015

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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.

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)

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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
- Comments Sought on Compliance Requirements Related to Production of Plant-Incorporated Protectants
Federal Register Notice (April 18, 2007) Exemption under FIFRA for Certain Plant-Incorporated Protectants Derived from Plant Viral Coat Protein Gene(s) (PVCP-PIPs)
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)