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Nonregulated GMOs
Mutagenesis
Cross breeding
Hybrids
Protoplast fusion
Polyploidy
Mass selection
CRISPR
Agrobacterium
transformation
Subgenics
ZFNs
TALONs
RNAi
Gene editing
Ballistic
transformation
Cysgenics
Transgenics
Regulated
GMOs
Part 340 revisions
Very narrow definition (i.e. 1 base pair vs 2
base pairs)
Increase over “Am I regulated” (no
transgene present) which many countries
including some or our largest ag
competitors operate under.
Center for Science in the Public Interest
The problem with this argument is that a science-
based regulatory system should base its oversight on
whether the plant possesses traits that make it a
potential plant risk, not the plant’s method of
production.
Canada regulates GE foods and crops under a broader category
it calls “Novel Foods” and “Plants with Novel Traits” which
includes products of GE as well as crops produced by other
technologies such as traditional breeding and mutagenesis
Process vs Product Based Regulations
induced mutagenesis, ethyl methanesulfonate (EMS)
Products with similar risks are not regulated in similar ways.
Center for Science in the Public Interest
The second problem is that the developer
self-determines if its product qualifies for an
exemption. This sets up an inherent conflict
of interest because developers have
financial incentives to determine
themselves exempt..
Where are the transparency
concerns when a mutation with
more than a single nucleotide is
achieved via natural selection or
mutation breeding?
Transparency
At what point does a technology becomes
tested and familiar enough that less
regulatory rigor is needed.
Shouldn’t there be a process that reviews
regulations to determine if they are
scientifically and economically justified.
Transparency
Plant Physiology Preview. Published on May 26, 2020, as
DOI:10.1104/pp.19.01194
Relevance of off-target changes in genome editing
Peter L. Morrell et al.
We should look at conflict of interest
from all angles. Regulators and activists
may have financial incentives and other
motives to not favor reduced regulation.
Transparency

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4 Keith Edmisten USDA Rule Panel, 6-5-2020

  • 1. Nonregulated GMOs Mutagenesis Cross breeding Hybrids Protoplast fusion Polyploidy Mass selection CRISPR Agrobacterium transformation Subgenics ZFNs TALONs RNAi Gene editing Ballistic transformation Cysgenics Transgenics Regulated GMOs
  • 2. Part 340 revisions Very narrow definition (i.e. 1 base pair vs 2 base pairs) Increase over “Am I regulated” (no transgene present) which many countries including some or our largest ag competitors operate under.
  • 3. Center for Science in the Public Interest The problem with this argument is that a science- based regulatory system should base its oversight on whether the plant possesses traits that make it a potential plant risk, not the plant’s method of production. Canada regulates GE foods and crops under a broader category it calls “Novel Foods” and “Plants with Novel Traits” which includes products of GE as well as crops produced by other technologies such as traditional breeding and mutagenesis Process vs Product Based Regulations
  • 4. induced mutagenesis, ethyl methanesulfonate (EMS) Products with similar risks are not regulated in similar ways.
  • 5. Center for Science in the Public Interest The second problem is that the developer self-determines if its product qualifies for an exemption. This sets up an inherent conflict of interest because developers have financial incentives to determine themselves exempt..
  • 6.
  • 7.
  • 8. Where are the transparency concerns when a mutation with more than a single nucleotide is achieved via natural selection or mutation breeding? Transparency
  • 9. At what point does a technology becomes tested and familiar enough that less regulatory rigor is needed. Shouldn’t there be a process that reviews regulations to determine if they are scientifically and economically justified. Transparency
  • 10. Plant Physiology Preview. Published on May 26, 2020, as DOI:10.1104/pp.19.01194 Relevance of off-target changes in genome editing Peter L. Morrell et al.
  • 11. We should look at conflict of interest from all angles. Regulators and activists may have financial incentives and other motives to not favor reduced regulation. Transparency