Abstract
This chapter provides a discussion on EPA regulation of pest control traits expressed in living plants, termed Plant-Incorporated Protectants (PIPs). These are regulated as pesticides and, as such, require assessment by EPA prior to field testing and commercialization. This chapter provides a discussion of EPA regulatory requirements for PIPs as well as a description of the data that EPA typically uses to make safety determinations.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
40 CFR 158 subpart V. Code of federal regulations title 40: Protection of environment, Part 158—Data requirements for pesticides, Subpart V—Microbial pesticides. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=46d22bc6e9a74d8f268ee0ee49f89201&rgn=div5&view=text&node=40:24.0.1.1.9&idno=40#40:24.0.1.1.9.16. Accessed June 27, 2012
40 CFR 158.2150. Code of federal regulations title 40: Protection of environment, Part 158—Data requirements for pesticides, Subpart V—Microbial pesticides, 158.2150—Microbial pesticides nontarget organisms and environmental fate data requirements. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=46d22bc6e9a74d8f268ee0ee49f89201&rgn=div5&view=text&node=40:24.0.1.1.9&idno=40#40:24.0.1.1.9.16.1.6. Accessed June 27, 2012
40 CFR 172 subpart C. Code of federal regulations title 40: Protection of environment, Part 172—Experimental use permits, Subpart C—Notification for certain genetically modified microbial pesticides. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=46d22bc6e9a74d8f268ee0ee49f89201&rgn=div5&view=text&node=40:24.0.1.1.22&idno=40#40:24.0.1.1.22.3. Accessed June 27, 2012
40 CFR 174.507. Code of federal regulations title 40: protection of environment, Part 174—Procedures and requirements for plant-incorporated protectants, Subpart W—Tolerances and tolerance exemptions, 174.507—Nucleic acids that are part of a plant-incorporated protectant; exemption from the requirement of a tolerance. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=46d22bc6e9a74d8f268ee0ee49f89201&rgn=div8&view=text&node=40:24.0.1.1.24.14.19.7&idno=40. Accessed June 27, 2012
Codex Alimentarius (2003) Foods derived from biotechnology. Alinorm 03/34: joint FAO/WHO food standard programme, Codex Alimentarious Commission, twenty-fifth session, Rome, Italy, 30 June–5 July 2003. Appendix III, Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants, and appendix IV, Annex on the assessment of possible allergenicity, pp 47–60
Guy RH, Hadgraft J (1991) Principles of skin permeability relevant to chemical exposure. In: Hobson DW (ed) Dermal and ocular toxicology: fundamentals and methods. CRC Press, Boca Raton
Ivanciuc O, Schein CH, Braun W (2003) SDAP: database and computational tools for allergenic proteins. Nucleic Acids Res 31:359–362
OECD (2006) Organisation for Economic Co-operation and Development (OECD) (2006) Series on harmonisation of regulatory oversight in biotechnology, no. 35, points to consider for consensus documents on the biology of cultivated plants. Environment directorate. Paris. Available online at http://www.oecd.org/dataoecd/36/17/46815838.pdf. Accessed June 27, 2012
Sanvido O, Stark M, Romeis J, Bigler F (2006) Ecological impacts of genetically modified crops, experiences from ten years of experimetnal field research and commercial cultivation. Agroscope Reckenholz-Tanikon Research Station ART, Zurich, 108 p
Saxena D, Stotzky G (2000) Insecticidal toxin from Bacillus thuringiensis is released from roots of transgenic Bt Corn in vitro and in situ. FEMS Microbiol Ecol 33:35–39
Sjoblad SJ, McClintock JT, Engler R (1992) Toxicological considerations for protein components of biological pesticide products. Regul Toxicol Pharmacol 15:3–9
Tapp H, Stotzky G (1998) Persistence of the insecticidal toxin from Bacillus thuringiensis subsp. kurstaki in soil. Soil Biol Biochem 30:471–476
USDA (2008) United States Department of Agriculture, Animal and Plant Health Inspection Service, Biotechnology Regulatory Services (2008) General document preparation guidelines for submission to BRS. http://www.aphis.usda.gov/brs/pdf/Doc_Prep_Guidance.pdf. Accessed 4 Jan 2012
USDA (2010) United States Department of Agriculture, Animal and Plant Health Inspection Service, Biotechnology Regulatory Services (2010) User guide for a notification. http://www.aphis.usda.gov/biotechnology/downloads/notification_guidance_0810.pdf. Accessed 4 Jan 2012
US. EPA (1996) Office of chemical safety and pollution prevention harmonized test guidelines, Series 885—Microbial pesticide test guidelines, Group D—Nontarget organism and environmental expression test guidelines, 885.4000—Background for nontarget organism testing of microbial pest control agents. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0159-0028. Accessed June 27, 2012
U.S. EPA (2000) Potato leaf roll virus resistance gene (also known as orf1/orf2)(006469) Registration eligibility document (BRAD). http://www.epa.gov/oppbppd1/biopesticides/ingredients/tech_docs/tech_006469.htm. Accessed 4 Jan 2012
U.S. EPA (2001) Biopesticide registration action document- Bacillus thuringiensis plant-incorporated protectants. http://www.epa.gov/oppbppd1/biopesticides/pips/bt_brad.htm. Accessed 4 Jan 12
U.S. EPA (2002) Office of chemical safety and pollution prevention harmonized test guidelines, series 870—Health effects test guidelines, group A—Acute toxicity test guidelines, 870.1100—Acute oral toxicity. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0156-0003. Accessed June 27, 2012
U.S. EPA (2004) Plant-incorporated protectant experimental use permit: process and compliance, proceedings. http://www.epa.gov/oppbppd1/biopesticides/pips/pip-eup-workshop/EUP%20Workshop%20main%20Final%20Proceedings.pdf. Accessed 4 Jan 2012
U.S. EPA (2006a) Insect resistance management fact sheet for Bacillus thuringiensis (BT) corn products. http://www.epa.gov/oppbppd1/biopesticides/pips/bt_corn_refuge_2006.htm. Accessed 04 Jan 2012
U.S EPA (2006b) Insect resistance management fact sheet for Bacillus thuringiensis (BT) cotton products. http://www.epa.gov/oppbppd1/biopesticides/pips/bt_cotton_refuge_2006.htm
U.S. EPA (2007) Guidance on small-scale field-testing and low-level presence in food of Plant Incorporated Protectants (PIPs), pesticide registration notice 2007–2. http://www.epa.gov/PR_Notices/pr2007-2.htm. Accessed June 27, 2012
U.S. EPA (2010a) Biopesticide registration action document – Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector PV-ZMIR13L) in MON 863 Corn (OECD Unique identifier: MON-ØØ863-5) PC Code: 006484 and Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector PV-ZMIR39) in MON 88017 Corn (OECD Unique Identifier: MON-88Ø17-3) PC Code: 006498. http://www.epa.gov/pesticides/biopesticides/pips/cry3bb1-brad.pdf. Accessed 04 Jan 2012
U.S. EPA (2010b) Biopesticide registration action document – modified Cry3A protein and the genetic material necessary for its production (Via Elements of pZM26) in event MIR604 Corn SYN-IR604-8. http://www.epa.gov/pesticides/biopesticides/pips/mcry3a-brad.pdf
U.S. EPA (2011a) Tips for Plant-Incorporated Protectant (PIP) Experimental Use Permit (EUP) program submission. http://www.epa.gov/pesticides/biopesticides/pips/pip_hints.htm. Accessed 04 Jan 2012
U.S. EPA (2011b) Current and previously registered section 3 plant incorporated protectants. http://www.epa.gov/oppbppd1/biopesticides/pips/pip_list.htm. Accessed 04 Jan 2012
U.S. FDA (1992) United States food and drug administration, guidance to industry on foods derived from new plant varieties. Fed Regist 57:22984–23005, May 29, 1992
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2012 US Government
About this chapter
Cite this chapter
Kough, J.L., Edelstein, R. (2012). EPA Regulatory Requirements for Plant-Incorporated Protectants. In: Wozniak, C., McHughen, A. (eds) Regulation of Agricultural Biotechnology: The United States and Canada. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-2156-2_10
Download citation
DOI: https://doi.org/10.1007/978-94-007-2156-2_10
Published:
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-007-2155-5
Online ISBN: 978-94-007-2156-2
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)