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.
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.
- Current and Previously Registered PIPs and their Risk Assessments
- Helpful Tip for Experimental Use Permits
Insect Resistance Management
- Insect Resistance Management for Bt Plant-Incorporated Protectants
- July 17-20, 2018 SAP Meeting: Resistance of Lepidopteran Pests to Bacillus thuringiensis (Bt) Plant Incorporated Protectants in the U .S.
- Framework to Delay Corn Rootworm Resistance
- December 4-6, 2013, SAP Meeting: Scientific Uncertainties Associated with Corn Rootworm Resistance Monitoring for Bt corn Plant Incorporated Protectants (PIPs)
- Insect Resistance Management General Docket
History of Regulating PIPs
- Agency Response to Greenpeace International et al. April 19, 2000
- October 2001 Reassessment of Bt PIPs for Corn, Cotton, and Potato Biopesticides Registration Action Document- Bacillus thuringiensis Plant-Incorporated Protectants (PDF) (30 pp, 340.45 K, About PDF)
- September 2003 Nature Biotechnology Article “Are Bt Crops Safe?”
- September 2010 Cry1Ab and Cry1F Corn Reassessment (PDF) (253 pp, 1.34 MB, About PDF)
- September 2010 Cry1A.105 and Cry2Ab2 Bt Corn Reassessment (PDF) (166 pp, 826 K, About PDF)
- September 2010 Cry3Bb1 Corn Reassessment (PDF) (234 pp, 978 K, About PDF)
- September 2010 Cry34/35 Bt Corn Reassessment (205 pp, 1.19 MB, About PDF)
- September 2010 mCry3A Corn Reassessment (141 pp, 578 K, About PDF)
- BT 10 corn issues: EPA Statement
- Biotech Information-Sharing MOU to Enhance Federal Agency Coordination - February 1, 2012
- Starlink Information: Search EPA Archive
Data and Risk Assessment for PIPs
- Plant-Incorporated Protectants Data Symposium (2016)
- Tier-Based Testing for the Effects of Proteinaceous Insecticidal Plant-Incorporated Protectants
- Consensus Document on Safety Information on Transgenic Plants Expressing Bacillus thuringiensis - Derived Insect Control Protein
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:
- Resistance of Lepidopteran Pests to Bacillus thuringiensis (Bt) Plant Incorporated Protectants in the U.S. (July 17-20, 2018)
- RNAi Technology as a Pesticide: Problem Formulation for Human Health and Ecological Risk Assessment. (January 28, 2014)
- Scientific Uncertainties Associated with Corn Rootworm Resistance Monitoring for Bt corn Plant Incorporated Protectants (PIPs). (December 4, 2013)
In the docket (www.regulations.gov):
- Efficacy of PIP Seed Blends and IRM Modeling for PIP Product (December 8, 2010)
- Scientific Issues Associated with Data Required to Register Plant-Incorporated Protectants (February 25, 2009)
- Evaluation of the Resistance Risks from Using a Seed Mix Refuge with Pioneer's Optimum AcreMax1 Corn Rootworm-Protected Corn (February 23, 2009)
- Evaluation of the Resistance Risks from Using 100% Bollgard and Bollgard II Cotton as Part of a Pink Bollworm Eradication Program in the State of Arizona (October 24, 2006)
- March 14 - 15, 2006: Event MIR604 Modified Cry3A Protein Bt Corn--Plant Incorporated Protectant
- March 1 - 2, 2005: Scientific Issues Associated With the Human Health Assessment of The Cry34Ab1 Protein
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
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)
- PIPs Exemption Proposal (Sept. 1, 2020)
- PIPs Exemption Final (May 24, 2023) (pdf)