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OECD Conference on Genome
Editing - Applications in Agriculture
28-29 June 2018
Regulatory Aspects – U.S. Environmental Pr...
2
In September 2016, EPA indicated in the National
Strategy for Modernizing the Regulatory System for
Biotechnology Produc...
3
EPA has exempted plant-incorporated protectants
(PIPs) from sexually compatible plants that occur
naturally in the plant...
4
EPA has also exempted residues of plant-incorporated
protectants (PIPs) from sexually compatible plants that
occur natur...
5
It has been argued that PIPs identical to these
exempted PIPs created using CRISPR / Cas9 and
similar techniques also fa...
6
The United States’ EPA is evaluating the extent to
which the current exemptions cover gene-edited PIPs
and considering a...
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Regulatory Aspects associated to genome editing – U.S. Environmental Protection Agency - Mike Mendelsohn

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In September 2016, EPA indicated in the National Strategy for Modernizing the Regulatory System for Biotechnology Products (put forward by the United States EPA, USDA, and FDA) that it intends to clarify its approach to pesticidal products derived from genome editing.

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Regulatory Aspects associated to genome editing – U.S. Environmental Protection Agency - Mike Mendelsohn

  1. 1. OECD Conference on Genome Editing - Applications in Agriculture 28-29 June 2018 Regulatory Aspects – U.S. Environmental Protection Agency Mike Mendelsohn, Chief Emerging Technologies Branch Office of Pesticide Programs 1
  2. 2. 2 In September 2016, EPA indicated in the National Strategy for Modernizing the Regulatory System for Biotechnology Products (put forward by the United States EPA, USDA, and FDA) that it intends to clarify its approach to pesticidal products derived from genome editing.
  3. 3. 3 EPA has exempted plant-incorporated protectants (PIPs) from sexually compatible plants that occur naturally in the plant or are moved through conventional plant breeding (40 CFR 174.25) from the United States Federal Insecticide, Fungicide, and Rodenticide (FIFRA) requirements, e.g. for product registration/licensing and field testing.
  4. 4. 4 EPA has also exempted residues of plant-incorporated protectants (PIPs) from sexually compatible plants that occur naturally in the plant or are moved through conventional plant breeding (40 CFR 174.508) from the United States Federal Food, Drug and Cosmetic Act (FFDCA) tolerance requirements, e.g. for pesticide residues in food or feed, provided the residues are not present in food at levels that are injurious or deleterious to human health.
  5. 5. 5 It has been argued that PIPs identical to these exempted PIPs created using CRISPR / Cas9 and similar techniques also fall within the 40 CFR 174.25 exemption. However, when this exemption was written in 2001, CRISPR / Cas9 (SDNs) did not exist as a gene editing technique.
  6. 6. 6 The United States’ EPA is evaluating the extent to which the current exemptions cover gene-edited PIPs and considering approaches to clarify the regulatory status of these materials.

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