NASEM Study Statement of Tasknas-sites.org/dels/files/2017/11/Susan-Koehler...5 Animal and Plant Health Inspection Service APHIS Biotech Regulation Related to Forest Health USDAAPHIS
United States Department of Agriculture Animal and Plant Health Inspection Service
Examine the potential use of biotechnology for mitigating threats to forest tree health
Identify the ecological, economic, social implications of deploying biotechnology in forests
Develop a research agenda to address knowledge gaps about its application
Focus on trees - at least two cases that consider the use of biotechnology to protect a tree species from an insect and/or disease that has negative consequences for forest health
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NASEM Study Statement of Task
Presenter
Presentation Notes
My thanks to NAS staff for putting together this excellent committee to undertake this study on the potential for biotechnology to address forest health. I appreciate the opportunity to present some background that sets the context for our interest in co-sponsoring this study and how we might use it.
United States Department of Agriculture Animal and Plant Health Inspection Service
Animal and Plant Health Inspection Service (APHIS) Mission – To protect the health and value of American agriculture and
natural resources APHIS Plant Protection and Quarantine (PPQ) forest pest mitigation,
research, and outreach APHIS Biotechnology Regulatory Service (BRS) biotech regulatory
framework APHIS BRS regulation of genetically engineered (GE) trees and other
organisms and biotech approaches that could impact forest health APHIS BRS evaluation process for deregulation How APHIS could use this study to support regulatory and non-regulatory
approaches that better support forest health.
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Overview
Presenter
Presentation Notes
The Animal and Plant Health Inspection Service (APHIS) is responsible for protecting U.S. agriculture and natural resources from plant pests and diseases. As such I will cover… Plant Protection and Quarantine (PPQ) current efforts to address pest and disease threats to forest health BRS’ biotechnology regulations and BRS’ experiences with confined releases of GE trees and other organisms, and biotech approaches that could impact forest health, and our integration of adaptive management BRS’ evaluation process for petitions for deregulation How APHIS can use information considered in the guiding questions for the case studies to improve both regulatory and nonregulatory approaches that support forest health.
United States Department of Agriculture Animal and Plant Health Inspection Service
Asian Longhorned Beetle >15 hardwoods at risk
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APHIS PPQ Forest Pest and Disease Programs Examples
PPQ has many forest pest control programs. Two of the most important ones are for non-native wood-boring beetles: Asian longhorned beetle & Emerald Ash Borer. ALB Since 1996 Asian Longhorned Beetle has been detected in 5 states Eradication is effective, but continues in NY, MA, and OH. It involves survey and removal of infested trees Imidicloprid trunk or soil injection to protect healthy trees Recommendations for restoration with non-host trees Quarantines are in place to restrict its movement and involves State Depts. of Ag and an outreach campaign EAB Since its 2002 discovery in Michigan , EAB has spread to at least 31 states despite an aggressive costly campaign to slow its spread with quarantines, surveys, tree removal, and public outreach programs in conjuction with state, local, and other federal agencies The effort is transitioning to IPM as APHIS is collaborating with the FS and ARS to implement a biological control program with Asian parasitic wasp species. Research is also focusing on more effective traps, lures and pesticides. Other active programs include those for the pine shoot beetle, gypsy moth, and the diseases European Larch Canker and Sudden Oak Death.
United States Department of Agriculture Animal and Plant Health Inspection Service
Sirex woodwasp • Threat to native pine forests in northeast US• Research with a nematode biocontrol agenthttps://www.aphis.usda.gov/plant_health/ea/downloads/SirexEA-final-northeast.pdf
Ambrosia beetles & Shot hole borers• Mostly polyphagous weevils• Tunnel mostly into stressed trees and cultivate fungi• Fungi can cause vascular tissue disease e.g. Redbay Laurel wilt http://www.plantheroes.org/polyphagous-shot-hole-borer; http://plantheroes.org/redbay-ambrosia-beetle
Rapid O’hia Death • Fungal disease of ʻōhiʻa trees in Hawaii• >90% mortality in 3 yrs.http://www.plantheroes.org/rapid-%C5%8Dhia-death ; https://cms.ctahr.hawaii.edu/rod/TheDisease.aspx
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Emerging Pests and Diseases of Concern to APHIS PPQ
Presenter
Presentation Notes
Emerging pest and diseases identified as concerns to PPQ include the following: Sirex woodwasp - APHIS is working with FS on research of a nematode BC agent to control this threat to native pines in the NE U.S. They led a working group to discuss pest status, spread, survey, control, and other needs. Ambrosia beetle and Shot hole borers are weevils that feed on many hosts. They tunnel into mostly stressed trees and cultivating fungi which then attach the vascular tissue causing wilt diseases such as Redbay laurel wilt. http://www.plantheroes.org/polyphagous-shot-hole-borer Rapid O’hia Death is a fungal disease of O’hia trees in Hawaii that can cause >90% mortality in just 3 years. Focus has been controlling movement of wood etc. Resistant varieties are needed – Research and outreach efforts typically involve multiple partners PPQ is not aware of any GE work yet for any of these forest pests or on sterile insects for these.
United States Department of Agriculture Animal and Plant Health Inspection Service5
APHIS Biotech Regulation Related to Forest Health
USDA APHIS Laws
• Plant Protection Act of 2000: ‒Consolidated from Plant Quarantine Act (PQA), Federal
Plant Pest Act (FPPA), and Noxious Weed Act. Biotechnology Regulations - 7 Code of Federal Regulations (CFR)
part 340 • Regulated Article: ‒Organism has been altered or produced through GE, and‒The organism is produced using plant pests (i.e. as a
donor, recipient or vector) or‒There otherwise is a reason to believe the organism is a
plant pest.
Presenter
Presentation Notes
The Plant Protection Act authorizes APHIS to protect plant health in the United States. This act was consolidated from several other laws; the Plant Quarantine Act, the Plant Pest Act, and the Federal Noxious Weed Act. Under the PPA, APHIS biotechnology regulations at 7 CFR part 340 currently regulate only certain genetically engineered organisms (GE) that may present a plant health risk. Regulated articles include… Organisms that have been altered or produced through GE, and The organism is produced using plant pests (i.e. as a donor, recipient or vector) or There otherwise is a reason to believe the organism is a plant pest. The definition of a regulated article and the lists of organisms we consider to be plant pests are defined in the regulation. In addition, BRS coordinates with other programs in APHIS, the Environmental Protection Agency and the Food and Drug Administration consistent with the principles of the Coordinated Framework for the Regulation of Biotechnology to ensure protection of plant health, the environment and food safety.
United States Department of Agriculture Animal and Plant Health Inspection Service6
What does APHIS BRS regulate?
Authorizations are required for regulated articles for:• Viable GE plants or parts, pests, or pathogens for…• Interstate movement or Importation, and • Release (confined trials) - permits to 3 yrs., renewable
BRS authorizations are not required if:• a petition for nonregulated status is granted or • if a GE organism falls outside the scope of 7 CFR part
340. View Letters at - https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/am-i-regulated/regulated_article_letters_of_inquiry/regulated_article_letters_of_inquiry
PPQ authorizations may still apply
Photo: USDA Plants Database
www.aphis.usda.gov
Presenter
Presentation Notes
Authorizations are required for regulated articles under 7 CFR 340: That are viable such as GE seeds, plantlets, stolons, insects or pathogens when they are Moved between states or imported, or for Environmental release (confined field trials) – permits are issued for up to 3 yrs, and are renewable BRS authorizations are not required If a petition for nonregulated status is granted E.g. a eucalyptus petition has been submitted, it is still pending. No others have been submitted Or based on the regulatory scope, they do not met the criteria for a regulated article. BRS has a streamlined “Am I Regulated” process for such determinations, and such an opinion was issued in 2014 to Arborgen for a Loblolly pine engineered without plant pest sequences PPQ authorizations may still apply, e.g. if the tree or plant products or pests are regulated by them.
APHIS BRS experience with Forest trees field trials is extensive. Most of those for which permits have been issued are listed here. Common non-confidential traits relative to forest health or management are listed. Based on the approved acreage over the timespan shown most of the focus has been in Eucalyptus, but other trees, especially poplars, Pines, American chestnut, Walnut and Elms have been permitted with resistance to pest or pathogens. Other traits (e.g. those in poplars) that could affect the health or management of the trees include modifications to wood, lignin, biomass, growth rates, herbicide resistance, fertility, suckering, and phytoremediation. (Acreage may include renewals of previous plantings as well. Serviceberry, apples, and other fruit tree permits have been issued for pest or pathogen resistance as well.)
United States Department of Agriculture Animal and Plant Health Inspection Service8
Confinement of GE Forest Tree Field Trialsand Adaptive Management
Confinement eliminates or minimizes inadvertent escape and persistence of GE traits/organisms, and
Limits potential adverse impacts to plant health, environment, T&E spp.
Permit conditions, inspections, and reporting requirements are used to avoid, report, and mitigate potential confinement breaches or impacts.
Permit conditions Flexible, implementable, enforceable and risk-based Allow for collection of meaningful data to inform adaptive
management
Consider many factors, e.g. plant biology, outcrossing, persistence, GE trait, trial site, land use history, ecological interactions, management
Presenter
Presentation Notes
GE forest tree field trials are conducted under confined conditions to eliminate or minimize inadvertent escape and persistence of GE traits/organisms, and limit potential adverse impacts to plant health, the environment and threatened or endangered species. USDA uses permit conditions, inspections, and reporting requirements to avoid and report potential confinement breaches or impacts. Permit conditions are or should: Be flexible, implementable, enforceable and risk-based When possible they allow for collection of meaningful data to inform adaptive management as trials progress in size and age. This can be a challenge for with large flowering trees with compatible relatives within pollination distance. Site selection, scouting, isolation and monitoring are critical. Sterility traits or single sex clones are sometimes used. Permits conditions and required reports consider many factors listed here e.g.: plant biology, outcrossing, persistence, GE trait, trial site, land use history, ecological interactions, and management
United States Department of Agriculture Animal and Plant Health Inspection Service9
Challenges Unique to GE Forest Tree Trials
Challenging Characteristics of GE Forest Tree Trials
American Chestnut
Pinus spp.(Loblolly)
Poplar spp.
Medium to Long- lived tall perennial Y Y Y
Juvenile period 8-10 Yrs >12-50 Yrs 4-15 Yrs
Prolonged reproductive stage Y Y Y
Long distance pollen dispersal N Y Y
Mostly outcrossing – gene flow possible Y (low) Y Y
Prolific seed production N Y Thousands Y Millions
Long distance seed dispersal N N Y Miles
Vegetative Reproduction stump sprouts N root suckers
Forest trees have characteristics that present some unique challenges during regulated field trials relative to most GE crops. These characteristics and environmental and human interactions can make confinement more difficult. They can also impact trait development such as altered flowering, fertility, and suckering as a solution. The longer juvenile period mitigates gene flow through seed and pollen, but makes tree breeding take longer. These characteristics and interactions are considered in our assessments for confined releases, and for petitions to allow unconfined releases. Three species illustrate some of these challenges: American chestnut is susceptible to chestnut blight which nearly eradicated the whole native chestnut population in the NE U.S. in the early 1900s after it was introduced from Asia. Bark cankers can lead to dieback of the upper branches after girdling branches or the tree trunk. Trees damaged by this pathogen or through copicing can still persist through stump sprouting. There is intense public interest in this species because of its former importance in mixed hardwood forests as a source of lumber, and the nuts for food and feed. http://www.sciencedirect.com/science/article/pii/S1878614613001748 Loblolly pine – is a pioneering species that can form pure stands, increasing fire hazard and is a host for pine beetles and Sirex woodwasp. It’s long distance pollen dispersal and high outcrossing make gene flow a concern for confinement given the thousands of seed produced on mature trees. It is also provides habitat for endangered species. http://vro.agriculture.vic.gov.au/dpi/vro/vrosite.nsf/pages/weeds_loblolly-pine Poplar species grow rapidly and flower earlier. Their high potential for pollen dispersal, outcrossing, seed production and seed dispersal over miles makes confinement challenging if trees are flowering. But it is mainly their prolific root suckering over 100s of feet over decades even after the original tree is removed that allows for long-term persistence. In nature they can form pure clonal stands. (Populus spp. OECD concensus document and USFSFEIS )
United States Department of Agriculture Animal and Plant Health Inspection Service10
GE Tree Poplar Field Trial Challenges
USDA APHIS
Suckers emerge where roots
were dug out.
Suckers emerge outside the deer fence.
Suckers can survive
herbicide spraysUSDA APHIS photos
Presenter
Presentation Notes
Suckers can emerge even after roots were dug out. Suckers can emerge outside trial perimeter where they may be browsed. Suckers can survive herbicide sprays. Methods to control suckers are evolving – permit conditions are being updated to reflect new methods.
United States Department of Agriculture Animal and Plant Health Inspection Service11
Other Unique Challenges and Opportunities
Guiding Question
(3) What other unique challenges and opportunities are posed by the development of a genetically engineered product for a non-commercial, public good such as forest health?
Possibilities include: • Soft funding sources to cover research and regulatory obligations• Public trust and engagement in the process • Partnerships and Cooperative agreements
APHIS can use this information to look for opportunities to address these challenges during the development phase.
Presenter
Presentation Notes
(3) What other unique challenges and opportunities are posed by the development of a genetically engineered product for a non-commercial, public good such as forest health? Possibilities include: Soft funding to cover research and regulatory hurdles Public engagement in the process may be more important to build trust Partnerships and Cooperative agreements could be used to leverage funding and help with public outreach – Forest Health Initiative is a good example Public engagement may provide better understanding and appreciation of the technology But it can also lead to lawsuits or field trial destruction or theft of both GE and non GE trees, thus delaying development. APHIS can use this information to consider solutions to these challenges and explore opportunities to address them.
United States Department of Agriculture Animal and Plant Health Inspection Service12
Evaluations for Unconfined Release
Petition Process for Nonregulated Status
Petition Evaluation - Comprehensive scientific review • Crop biology and taxonomy• Genotypic and phenotypic differences• Field test reports for APHIS authorized releases• Data and publications relevant to a determination
• Plant Pest Risk Assessment (PPRA) - (Plant Protection Act)
• Biological Assessment (BA) - (Endangered Species Act)
Presenter
Presentation Notes
When a developer submits a petition to APHIS to determine that a regulated articles does not pose a plant pest risk, a multidisciplinary team of scientists conducts a comprehensive scientific review of the petition which includes information on Crop biology and taxonomy Genotypic and phenotypic differences compared from the unmodified species Field test reports for APHIS authorized releases, and any Data and publications relevant to a determination If a petition is deemed complete APHIS conducts three assessments: Plant Pest Risk Assessment (PPRA) - to determine if the GE organism poses a risk as a plant pest (Plant Protection Act). This is the central document that is the basis of our regulatory response to a petition for non-regulated status. The considerations are aligned with information required to be submitted in a petition specified in the regulation. Environmental Assessment (EA) or Environmental Impact Statement (EIS) – is prepared consistent with the National Environmental Policy Act; NEPA to inform APHIS and others about potential environmental impacts before APHIS makes its regulatory determination under the PPA. APHIS can consider regulatory alternatives and their potential environmental impacts, as well as other impacts to public health and endangered species. But NEPA does not provide APHIS any additional regulatory authority to address environmental impacts beyond what the Plant Protection Act provides. Public comment is sought on the petition and the EA or EIS consistent with regulatory requirements, and comments are addressed in the final assessments. Biological Assessment is prepared to determine effects of the proposed action on threatened or endangered species. If the assessment or informal consultation with the Services concludes that the proposed APHIS action is likely to adversely affect species or their critical habitat, a more formal consultation is necessary.
United States Department of Agriculture Animal and Plant Health Inspection Service13
Potential for Biotechnology to Improve Forest Health
Guiding Questions(1) What is the current state of the science regarding the potential for using genetic engineering and similar technologies in trees to improve forest health?
(4) What research is needed to fill knowledge gaps about developing and using genetic engineering as a tool to protect forest health?
Possible considerations (also relevant to APHIS PPRAs): • GE tree biology and traits to improve forest health• GE tree pests, pathogens, symbionts, or biocontrol agents• New techniques e.g. gene drives or targeted gene editing, deletions, or silencing• Specificity, efficacy and durability of resistance traits or pest suppression• Variability and prevalence of pest, pathogen, host and environmental interactions• Off-target effects• Impacts on agricultural practices and IPM approaches• Geneflow and weediness impacts from inheriting the engineered trait
Presenter
Presentation Notes
(1) What is the current state of the science regarding the potential for using genetic engineering and similar technologies in trees to improve forest health? (4) What research is needed to fill knowledge gaps about developing and using genetic engineering as a tool to protect forest health? Possible considerations here that are also relevant to our plant pest risk assessments for petitions include e.g. GE tree biology and traits that could improve forest health, but also… Genetic engineering of tree pests, pathogens, symbionts, or biocontrol agents – by way of example BRS has issued permits for GE chestnut blight with reduced virulence, and a citrus virus engineered to control a citrus bacterial disease, as well other GE plant pathogenic bacteria, endophytes insects, and an insect-infecting nematode Potential for use of new techniques such as gene drives, gene deletions, silencing or editing in any of these organisms to improve forest health Specificity, efficacy and durability of resistance traits or pest suppression- Is it effective against multiple strains? Does it include stacked traits? Variability and prevalence of pest, pathogen, host and environmental interactions, including, e.g. pest susceptibility, pathogen strains, pest prevalence. Off-target effects Compatibility with IPM approaches, e.g. pesticides, biocontrol, etc. Impacts on weediness of the tree and other species that inherit the transformed DNA?
United States Department of Agriculture Animal and Plant Health Inspection Service14
APHIS Information Needs and Research
APHIS can use information from the NASEM study to inform data for regulatory decisions, as well as priorities for research or support documents.
Examples include:• OECD consensus documents on biology of forest trees• OECD consensus documents on ecological risk assessment• USDA NIFA and BRAG program grants• Farm Bill supported suggestions under Section 10007
Presenter
Presentation Notes
APHIS can use this information to inform data requested and reviewed for regulatory decisions for permits or petitions, as well as priorities for research or support documents. Examples include: OECD consensus documents on biology of forest trees OECD concensus documents on ecological risk assessment NIFA and BRAG program grants Farm Bill supported suggestions under Section 10007
United States Department of Agriculture Animal and Plant Health Inspection Service15
Developing a Risk Framework for Forest Health
Guiding Questions (5 & 6)
• In what ways does the current regulatory system include forest health in evaluating the ecological and environmental risks of deploying GE trees?
• How does this compare with regulatory evaluation of impacts for other methods used to address forest health threats e.g. non-GE trees or biological control or pesticides?
• What information or analysis is needed to inform a risk framework that provides assurances for minimizing the risks of using GE while increasing benefits to forest health?
• What characteristics of forest health are central to a risk framework?
• How can adaptive management be used to enable realistic testing and assessment of biotech approaches for mitigating forest health threats?
Presenter
Presentation Notes
In what ways does the current regulatory system include forest health in evaluating the ecological and environmental risks of deploying GE trees? How does this compare with evaluation of other methods used to address forest health threats e.g. non-GE trees or biological control or pesticides? What information or analysis is needed to inform a risk framework that provides assurances for minimizing the risks of using GE while increasing benefits to forest health? What characteristics of forest health are central? How can adaptive management be used to enable realistic testing and assessment of biotech approaches for mitigating forest health threats? What information do agencies need to assess at different stages to decide what and how to regulate or not, or what program to implement? BRS and APHIS PPQ assessments for plant pest risks, environmental assessments and TES impacts EPA ecological and human health risk assessments and benefits analysis for plant incorporated protectants, and labels USFS pest management programs There is no such thing as zero risk. remember…
United States Department of Agriculture Animal and Plant Health Inspection Service16
Forest Health is Declining!
Risks Benefits
GE vs Traditional Tree
GE Pest or Pathogen
Biocontrol
Pesticide
Rapid ʻŌhiʻa Death – rapid browning of tree crown
Photo by J. B. Friday University of Hawaii College of Tropical Agriculture and Human Resources
Forest Health is Declining! How can our risk assessment and regulatory framework be more efficient and effective as we consider the options? How can we use our regulatory authority to better improve forest health? Photos: https://www.nps.gov/havo/learn/nature/rapid-ohia-death.htm
United States Department of Agriculture Animal and Plant Health Inspection Service17
Developing a Risk-Based Regulatory Framework for Forest Health
APHIS can use this information to improve a risk-based regulatory framework for forest health
Reconsider critical information needed to inform APHIS regulatory decisions in PPQ and BRS and supporting risk assessments, environmental documents, and monitoring
How is forest health measured and what standards should apply
How best to obtain and analyze the information Harmonize, generate or share data, or cooperate with other agencies
on assessments and scoping for GE trees or other organisms
Presenter
Presentation Notes
APHIS can use this information to improve a risk framework for forest health Reconsider critical information needed to inform APHIS regulatory decisions in PPQ and BRS and supporting risk assessments, environmental documents, and monitoring: When regulation is necessary – what permit conditions to apply Hypothesis driven data collection for reports and petitions Plant Pest and Weed Risk assessment Quarantine, eradication and control programs, including restoration Environmental impacts of preferred and reasonable alternatives ESA Assessments Consider how forest health is measured, what standards should apply Consider how best to obtain and analyze the information – E.g. information or data provided by applicants, nonprofit organizations, academic research, through Grants, Farm Bill funds etc. How to deal with uncertainty from variability or absence of data. When possible, harmonize, generate or share data, or collaborate or cooperate with other agencies (e.g. EPA, ARS, USFS, NRCS, FWS) on assessments and scoping for GE trees or other organisms to improve forest health.
United States Department of Agriculture Animal and Plant Health Inspection Service18
Interagency Cooperation on Risk Assessments for Forest Health
USDA-Forest Service provided scientific and editorial assistance and three technical reports for the Environmental Impact Statement for the GE-Freeze Tolerant Eucalyptus (FTE) petition:
Projecting potential adoption of GE-FTE plantations Implications for expansion of GE-FTE plantations on water
resources Evaluation of potential fire behavior in GE-FTE plantations
of the Southern U.S.
Presenter
Presentation Notes
For example the USDA’s Forest Service was a cooperating agency providing review and technical assistance on our EIS for the freeze tolerant Eucalyptus petition, producing 3 technical reports, projecting adoption rates of plantations of these trees, implications for expansion of these plantations on water resources of the U.S., and evaluation of their potential fire behavior in the southern U.S. Other agencies also provided assistance during the field release stage.
United States Department of Agriculture Animal and Plant Health Inspection Service19
Socio-Economic Implications of Biotech Approaches for Forest Health
Guiding Question
(2) What are the potential ecological and economic impacts of deploying trees protected from pests and pathogens using biotechnology?
• Consider agencies’ legal authority, obligations, and options • Economic and trade implications
(7) What does existing research reveal about public views on the use of biotechnology to improve forest health?
• Will society be more accepting in the absence of viable alternatives? • Will this affect the ultimate use of these approaches?
APHIS can use this information to improve scoping and analysis of socio-economic implications of action alternatives in our NEPA documents.
Presenter
Presentation Notes
Lastly…What are the social and economic implications of using or not using genetic engineering to improve forest health? E.g. Consider the legal authority, obligations, and options of the authorizing agency – e.g. under NEPA and executive orders – public comment is sought on all these documents and is considered in the final documents. Could there be economic or trade implications from GE trees vs other approaches e.g. regarding health, pesticides, and pests or the GE status of lumber Will society be more accepting of biotech approaches to forest health if there is an absence of viable alternatives? Will this affect their ultimate use? APHIS can use this information to improve scoping and analysis of the social, economic implications of action alternatives in our NEPA documents.
United States Department of Agriculture Animal and Plant Health Inspection Service
APHIS-BRS website for permit and petition-related documents: https://www.aphis.usda.gov/aphis/ourfocus/biotechnology
See APHIS-PPQ, Plant Health Programs website for information on plant pest and disease programs: https://www.aphis.usda.gov/aphis/ourfocus/planthealth/plant-pest-and-disease-programs/pests-and-diseases
