Abstract
The policy of the United States government is to seek regulatory approaches, consistent with applicable laws, that protect health and the environment while reducing unnecessary regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating unnecessary trade barriers [Adapted from the National Strategy for Modernizing the Regulatory System for Biotechnology Products, Product of the Emerging Technologies Interagency Policy Coordination Committee’s Biotechnology Working Group (OSTP 2016)]. U.S. agencies are focused on delivering health and environmental protection based on the best available science; establishing transparent, coordinated, predictable, and efficient regulatory practices across agencies; and promoting public confidence in the oversight of the products of biotechnology through clear and transparent public engagement [Adapted from the Task Force on Agriculture and Rural Prosperity Report (USDA 2017)]. U.S. agencies that regulate the products of agricultural biotechnology discuss regulatory approaches presented during the June 2018 OECD Conference on Genome Editing Applications in Agriculture, focusing on plants developed using genome editing.
References
EPA (Environmental Protection Agency) (2001a) Regulations under the federal insecticide, fungicide, and rodenticide act for plant-incorporated protectants (formerly plant-pesticides). Fed Reg 66:37771–37817
EPA (Environmental Protection Agency) (2001b) 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). Fed Reg 66:37830–37854
NASEM (National Academies of Sciences, Engineering, and Medicine) (2017) Preparing for future products of biotechnology. The National Academies Press, Washington, DC. https://doi.org/10.17226/24605
OSTP (Office of Science and Technology Policy) (1986) Coordinated framework for the regulation of biotechnology. Fed Reg 49:50856–50907
OSTP (Office of Science and Technology Policy) (2016) National strategy for modernizing the regulatory system for biotechnology products. https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/biotech_national_strategy_final.pdf. Accessed 1 Nov 2018
OSTP (Office of Science and Technology Policy) (2017) Modernizing the regulatory system for biotechnology products: final version of the 2017 update to the coordinated framework for the regulation of biotechnology. https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf. Accessed 1 Nov 2018
USDA (United States Department of Agriculture) (2017) Report to the president of the United States from the task force on agriculture and rural prosperity. https://www.usda.gov/topics/rural/rural-prosperity. Accessed 1 Nov 2018
USDA (United States Department of Agriculture) (2018) Secretary perdue issues USDA statement on plant breeding innovation. https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/brs-news-and-information/2018_brs_news/plant_breeding. Accessed 1 Nov 2018
USDA-APHIS (United States Department of Agriculture-Animal and Plant Health Inspection Service) (1987) Introduction of organisms and products altered or produced through genetic engineering which are plant pests or which there is reason to believe are plant pests. Fed Reg 52:22892–22915
Author information
Authors and Affiliations
Corresponding author
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Disclaimer: Sally L. McCammon is a Science Advisor at BRS, APHIS, USDA. “The Findings and Conclusions in This Preliminary Publication Have Not Been Formally Disseminated by the U. S. Department of Agriculture and Should Not Be Construed to Represent Any Agency Determination or Policy”.
Mike Mendelsohn is Chief of the Emerging Technologies Branch in BPPD, OPP, EPA. “The Findings and Conclusions in This Preliminary Publicaton Have Not Been Formally Disseminated by the U.S. Environmental Protection Agency and Should Not be Construed to Represent Any Agency Determinations or Policy”.
Disclaimer: The opinions expressed and arguments employed in this paper are the sole responsibility of the author and do not necessarily reflect those of the OECD or of the governments of its Member countries.
Rights and permissions
About this article
Cite this article
McCammon, S.L., Mendelsohn, M. Innovation and the regulation of products of agricultural biotechnology in the United States of America. Transgenic Res 28 (Suppl 2), 183–186 (2019). https://doi.org/10.1007/s11248-019-00150-5
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11248-019-00150-5