International Legal Landscape Lori P Knowles Panel Questions The - - PowerPoint PPT Presentation

GE Trees on the International Legal Landscape

Lori P Knowles

Panel Questions

 The challenges the U.S. regulatory system presents for developing and releasing unmanaged GE organisms, like trees for forest health, into the environment: and how they think the current system should deal with those challenges.  Whether other countries’ regulatory systems deal with those challenges  Whether it would be a problem if a GE tree originating in the U.S. spread into Canada (or vice versa) and how the two countries would address that spread across the international boundary

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Differences and similarities across regulatory regimes

• Most biotech regulatory schemes created with agricultural crops in

mind, and do not specifically address issues that pertain to trees

• Levels of acceptable risk associated with deregulation of GE

plants or tree products differ

• In all risk assessment gene flow is a factor considered
• Regulatory triggers; Characteristics and intended use (plant pest)

US; Novelty CAN; Genetic Engineering or GMO Brazil and EU

• Product vs Process distinction

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Europe

• Experiences with food safety and biosafety crises create cultural

environment in Europe as GM crops hit markets.

• Precautionary approach to approving the commercialization of GE crops
• Has been described as “zero-risk” environment
• Assessment and approval triggered by process used to introduce a trait

into an organism

• GMO = “Organisms in which the genetic material has been altered in a

way that does not occur naturally by mating and/or natural recombination”

• EU Directive 2001/18/EC and EFSA Guidances

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Science in the News,

• K. Lyon, from Same

Science Different Policies, Harvard Medical School, Harvard University

https://ec.europa.eu/food/see-the/infographics-factsheets_en accessed March 5, 2018

Brazil

• 2005 Brazilian Biosafety law, Law No.11, 105
• Like EU - separates a technical assessment body, The National

Technical Commission of Biosafety (CTNBio) from political decision making body, The National Biosafety Council (CNBS)

• Each biotech product is treated on a case-by-case basis.
• No regulations or systems tailored specifically for biotech trees, but

GE Eucalyptus was approved in April, 2015 for commercial release.

Costanza, A., & McCord, S. (2013). Regulation, Certification, and Use of Biotech Trees. Institute of Forest Biosciences, Cary, NC. URL: http://www.forestbio.org/biotech_tree_use

Canada

• GM trees fall into the same regulatory framework as GM crops

1993- Health Canada/Environment Canada/Canadian Food Inspection Agency

• No GM specific regulation to allow for single risk management

system (a stated goal)

• Trigger of regulation focuses on NOVELTY of product - Directives

2000-07 (Field Trials) and 94-08 (Assessment Criteria for determining E Safety of PNT), Directive 2009-09

• Risk-based assessment based on novelty and potential for harm as

compared to non-GE counterpart

Field trials

• Deregulation in US = Authorization in Canada
• Authorizations: confined field trials (most research

projects) with small sizes,CFIA inspection and monitoring OR unconfined release into the Canadian environment with limited or no conditions

• Federal and Provincial Jurisdiction issues: Authorization

for release is federal, but since provinces have jurisdiction

• ver forestry the CFS must work with provincial ministries
• f Natural Resources to manage and monitor field trials.

Plants with Novel Traits

• Based on the interpretation of the exemption criteria given

in Part V of the Seeds Regulations, the Plant Biosafety Office (PBO) defines plants with novel traits (PNTs) as plants into which one or more traits have been intentionally introduced, regardless of method, where: The trait is new to cultivated populations of the species in Canada, AND the plant has a potential to have a significant negative environmental effect.

Significant negative environmental impact

Exemptions from Novelty

• Plant was cultivated before 1996
• Plant is derived from a previously authorized

product

• Products expresses trait that is within the range of

expression found in the wild populations - within natural variations

• 2015 Authorization of Arctic Apple - for unconfined

release (in orchards)

• Safety for humans (Health Canada) and for livestock

and the environment (CFIA)

• In 100 small supermarkets around Oklahoma

GE Petunia

• One of a few GE plants that are not being regulated as PNT
• Not considered a PNT because the determination was made

that they do not pose any more environmental risk than conventional petunias “Following a science-based analysis, the CFIA has determined that these GE petunias pose no more risk to the environment than conventional petunias. Therefore, they are not considered to be a plant with novel traits and will not be regulated in Canada.”

• So, although they are GE, they are not regulated

Gene Editing/CRISPR

• Discussions about gene editing taking place in Europe and

Canada

• EU: Does a gene-edited organism fall outside the definition
• f a GMO in the EU Directive? Could the mutagenesis

exemption apply to gene-edited products? EU Ct Justice

• ngoing case.
• Canada: Could a gene-edited plant fall into the exemptions

for PNT? Post within 6 months from CFIA

• Will gene-editing be regulated differently? Social as well as

scientific issue

Pests and genes across borders

• Impact of inadvertent gene flow

“Yes, it would be a problem if the product was not approved in both jurisdictions. The company/individual should seek and attain regulatory approval from both the USA and Canada before releasing the product into the environment. If the unapproved tree made its way into Canada without approval, it would be non-compliant. Canada would then evaluate the associated risk of the product and determine appropriate risk management and compliance actions to mitigate the risk. This could include agreements on corrective action plans with the company/individual and government, or the government taking legal actions against the individual party. The exact steps would depend on the situation.”

• Mechanism for regulatory harmonization does exist:

Canada United States Regulatory Cooperation Council

• Long history of cooperation between APHIS/PPQ and

CFIA on phytosanitary issues

Social License

• Commercial introduction of GE crops accompanied by a high

level of civil tension; public perceptions of utility, risk and benefit of ag biotech differ markedly from those of industry

• We expect this tension to be higher with trees, AND YET,

the benefit, or imperative to act may be different and the motivation of environmental welfare and preservation of biodiversity may change the social license

• As industry backs away from this work, may need another

framework to think about the imperative for forest health solutions

Vaccine development analogy

• Public Health Crisis analogous to Forest Health Crisis
• Small confined field trials with purposeful intermingling of wild type and GM

trees with desired trait. Gene flow is desired. Does it confer the desired resistance? Population trials

• Can development of disease and pest resistance become akin to vaccine

manufacture?

• Incentives for development: Orphan Drug programs, special IPRs
• Limited liability: Vaccine Shield laws
• Sharing of information to facilitate: Open Forestry https://openforestry.org/
• Public research investment: and need similar government funding or PPP