Genetically engineered crops that fly under the US regulatory radar

Abstract

This Federal Register notice announces the policy of the federal agencies involved with the review of biotechnology research and products. As certain concepts are new to this policy, and will be the subject of rulemaking, the public is invited to comment on these aspects which are specifically identified herein. DATE: Comments must be received on or before August 25, 1986. Public Participation: The Domestic Policy Council Working Group on Biotechnology through the Office of Science and Technology Policy is seeking advice on certain refinements published herein to the previously published proposed coordinated framework for regulation of biotechnology. These new aspects include the Biotechnology Science Coordinating Committee's (BSCC's) definitions for an "ontogenetic organism (new organism)" and for "pathogen." These definitions are critical to the coordinated framework for the regulation of biotechnology because they establish the types of the organisms subject to certain kinds of review. The interagency coordination mechanism, the Biotechnology Science Coordinating Committee (BSCC), discussed in more detail in section C, of this Preamble, came into being while the agencies were still in process of refining their regulatory proposals. Consequently, the BSCC was able to play a helpful role in the formulation of two basic principles: (1) Agencies should seek to adopt consistent definitions of those genetically engineered organisms subject to review to the extent permitted by their respective statutory authorities; and, (2) agencies should utilize scientific reviews of comparable rigor. The regulatory framework anticipates that future scientific developments will lead to further refinements. Experience with earlier basic scientific research has shown that as the science progressed and became better understood by the public, regulatory regimens could be modified to reflect more complete understanding of the potential risks involved. Similar evolution is anticipated in the regulation of commercial products as scientists and regulators learn to predict more precisely particular product use that require greater or lesser controls or even exemption from any federal review. This framework has sought to distinguish between those organisms that require a certain level of federal review and those that do not. This follows a traditional approach to regulation. Within agriculture, for example, introductions of new plants, animals and microorganisms have long occurred routinely with only some of those that are not native or are pathogenic requiring regulatory approval. It should be noted that microorganisms play many essential and varied roles in agriculture and the environment and that for decades agricultural scientists have endeavored to exploit their advantages through routine experimentation and introduction into the environment; and as a rule these agricultural and environmental introductions have taken place without harm to the environment. B. The Coordinated Framework for the Regulation of Biotechnology General Comments...

Towards social acceptance of plant breeding by genome editing

“…This modern genome-editing can produce novel plants that are similar or identical to plants generated by conventional breeding techniques, thus creating indistinct boundaries with regards to GMO regulations [4][5][6][7][8]. Therefore an appropriate regulatory response is urgently required towards the social acceptance of genome-edited crops.…”

“…Otherwise, the imprudent use of genome-editing may lead to its rejection in agricultural and environmental applications. The regulatory response to genome-editing of plants has been considered or a decision has already been made in Argentina, Australia, the EU, New Zealand, and the USA [4,8]. with a low amylose content, Milky Queen, which underwent random mutagenesis using…”

“…[http://ipts.jrc.ec.europa.eu/publications/pub.cfm?id=4100] [4][5][6][7][8]. This modern genome-editing can produce novel plants that are similar or identical to plants generated by conventional breeding techniques, thus creating indistinct boundaries with regards to GMO regulations [4][5][6][7][8].…”

“…In general, the process-based GMO regulations are stricter than the product-based GMO regulations, thus requiring more time to gain regulatory approval [4,8,33,38,39].…”

A future scenario of the global regulatory landscape regarding genome-edited crops

“…The transgene-free plants developed via genome editing might bypass product-based GMO regulation. Moreover, some experts and interest groups have advocated that such transgene-free crops should not be regulated, even under process-based GMO regulations (Hartung and Schiemann, 2014;Camacho et al, 2014;European_Academies'_Science_Advisor-y_Council, 2015;European_Plant_Science_Or-ganisation , 2015;European_Seed_Association, 2015). Others disagree (GM_Freeze, 2016;GMWATCH, 2014;Green_Peace, 2015;IFOA-M_EU, 2015).…”