Forest Health and Biotechnology Possibilities and Considerations (2019) / Chapter Skim
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6 Current Regulatory System for Biotech Trees and Other Methods Used to Address Forest Health
6 Current Regulatory System for Biotech Trees and Other Methods Used to Address Forest Health
Pages 155-174
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From page 155... ...
and whether those regulatory systems make approval decisions that take into account the broad range of issues in this report's definition of forest health. Biotech trees developed to address forest health are regulated under the same statutes and regulations as any biotech plant, including commercial biotech trees (such as the virus-resistant papaya, nonbrowning apple, or cold-tolerant eucalyptus)
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From page 156... ...
The application of the Coordinated Framework to specific products means that biotech trees and plants may be regulated by zero, one, two, or three or more agencies.4 U.S. DEPARTMENT OF AGRICULTURE USDA is the first or primary agency that regulates some biotech plants.
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From page 157... ...
That document is not specifically required to address broad forest health concerns, only plant pest concerns. However, if forest health would be impacted because the biotech tree might have a plant pest concern, such as it could become invasive or have an impact on nontarget organisms, then those issues would be assessed in the Plant Pest Risk Assessment.7 In addition to addressing any plant pest issues with a biotech plant, any decisions by USDA to issue a permit for a field trial or to grant a petition for nonregulated status also must comply with the National Environmental Policy Act (NEPA)
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From page 158... ...
. To the extent that USDA is going to assess forest health issues involving biotech trees, it is likely to occur in its compliance with NEPA (except for plant pest issues that address forest health, which are analyzed in a Plant Pest Risk Assessment)
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From page 159... ...
Unapproved, 54 Approved, 387 FIGURE 6-2 Approved and unapproved permits for biotech trees submitted to the U.S. Department of Agriculture.
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From page 160... ...
. Unless the regulations in 7 CFR Part 340 are revised, it is safe to assume that there will be future biotech trees, including trees developed to address forest health, that will not 11Judgment of 25 July 2018, Confédération paysanne and others, C-528/16, EU:C:2018:583.
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From page 161... ...
. Thus, it is fair to say that if USDA conducts an EIS under NEPA for a biotech tree developed for forest health, it would likely assess a number of environmental and ecological parameters and services that would fall within this committee's definition of forest health.
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From page 162... ...
Therefore, since the primary way that USDA's oversight under the Plant Protection Act considers forest health issues is through compliance with NEPA, and the historical rate of conducting an EIS and EA for a biotech tree is very low, then without substantial revision to regulatory statues, guidelines, or practice, most biotech trees will not be comprehensively evaluated for their impacts on forest health, as defined in this report. In addition, the NEPA process is procedural, so it does not provide USDA with any authority to address forest health impacts that are identified in an EA or EIS.
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From page 163... ...
The committee specifically heard from stakeholders about their criticisms of that regulatory system as it applies to biotech trees developed to address forest health (Campbell, 2018; Costanza, 2018; Petermann, 2018; Strauss, 2018)
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From page 164... ...
Determining the regulatory pathway before a product is developed would be speculative. How ever, for any biotech tree solution, the oversight would be no greater than what is likely for the transgenic American chestnut as that product is regulated by all three possible agencies.
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From page 165... ...
. MOVEMENT OF BIOTECH TREES DEVELOPED TO ADDRESS FOREST HEALTH ACROSS NATIONAL BORDERS A unique aspect of a biotech tree developed to address forest health is that it will result in an unconfined release into the environment that is meant to propagate, spread, and persist without human oversight and control; this is significantly different from previously developed biotech trees, which are meant to be grown in orchards or plantations, and biotech crops, which are grown on managed farms.
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From page 166... ...
CURRENT REGULATORY SYSTEM FOR OTHER INTERVENTIONS TO ADDRESS FOREST HEALTH Independent of whether biotech trees are developed and deployed to address forest health issues, there are and will continue to be other methods utilized to address forest health concerns. This includes the use of pesticides, biological control agents, and introduction of tree varieties with resilience characteristics produced through selective-breeding methods.
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From page 167... ...
Regulation of Biological Control Agents to Address Forest Health Biological control agents are another method to address the impacts of insect pests and pathogens on forest health. USDA regulates biocontrol agents under the "plant pest" provisions of the Plant Protection Act, which is the same program that regulates certain biotech plants and trees.
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From page 168... ...
For a biotech tree regulated by EPA, EPA oversight continues after registration and conditions could be placed on how the tree is planted in the environment. It is anticipated, for example, that the biotech American chestnut tree will be reintroduced through plantings on private lands.
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From page 169... ...
, "there are no written guidelines or policy for introductions" within the historical range, augmentation of an existing population, and translocation (Johnson et al., 2013; Communication from the U.S. Fish & Wildlife Service, Washington, DC, to the National Academies of Sciences, Engineering, and Medicine's Committee on the Potential for Biotechnology to Address Forest Health, March 2018)
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From page 170... ...
Conclusion: The current regulatory framework that applies to biotech trees that are developed to address forest health encapsulates very few elements of the committee's comprehensive definition of forest health. If a biotech forest tree falls within the legal mandate of USDA, EPA, and/or FDA, then they regulate the tree the same as other biotech plants.
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From page 171... ...
Other interventions to address forest health, such as pesticides, biological control agents, and assisted migration, also may require federal government review and oversight before deployment. When reviewing the regulatory processes for those interventions and the risk analysis conducted by the regulatory agency, the assessments or reviews conducted do not do a better job of incorporating forest health and ecosystem services into their analysis than the assessments conducted for biotech trees.
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From page 172... ...
Private landowners can plant virtually any commercially available tree on their lands, whether a native species, a nonnative species, or a biotech tree. Recommendation: Regulatory agencies should explore ways to incorporate into their regulatory oversight responsibilities the ability to assess the impact on ecosystem services for biotech and nonbiotech products developed for improving forest health.
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From page 173... ...
Webinar presentation to the National Academies of Sciences, Engineering, and Medicine's Com mittee on the Potential for Biotechnology to Address Forest Health. Available at http://nas-sites.org/dels/files/2018/02/ Robyn-Rose-Presentation.pdf.
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From page 174... ...
2008. Forest Service Manual, National Headquarters (WO)
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