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The U.S. Perspective on Problem
Formulation for Biopesticides
PRESENTED AT THE 12 TH EXPERT GROUP ON BIOPESTICIDES SEMINAR:
PROBLEM FORMULATION FOR THE RISK ASSESSMENT OF BIOPESTICIDES
Shannon Borges, Deputy Director
Biopesticides and Pollution Prevention Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
Problem Formulation Basics
• Begins with a planning dialog to ensure that the risk
assessment enables risk managers to make informed
decisions
• Define the regulatory action
• Establish management or protection goals (e.g., maintaining a
sustainable aquatic community)
• Determine management options (e.g., restricting uses,
requiring specific personal protective equipment)
• Determine the preliminary scope and complexity of the risk
assessment
Problem Formulation Basics
• Problem formulation – establishing a foundation for the risk
assessment
• Integrate available information – how much is available and of
what quality
• Evaluate the nature of the problem – use patterns,
environmental fate, nontarget hazard
• Select assessment endpoints – what entity and characteristics
of that entity are to be protected
• Develop conceptual model – visual depiction of fate in the
environment and exposure pathways
• Develop an analysis plan – establish risk hypotheses and
analyses to test them
Starter Questions – Framing the Analysis
• Is the biopesticide novel; have we seen something similar or is it completely new?
• If not novel (e.g., new strain of a microbial pesticide), what do we know about it already?
• What information was submitted from the applicant and are there data gaps?
• What is indicated in the scientific literature?
• Does it help address any data gaps?
• Does it raise additional questions?
• What are the hazards indicated, if any?
• What are the use patterns and potential routes of exposure?
• If risks are identified, what mitigations are available?
The Importance of Product Identity
• Establishes the foundation for biopesticide problem formulation
• Identifies the active ingredient and its defining characteristics
• Defines data needs and sets the scope of the analysis
• Due to complicated make-up of some microbial and biochemical pesticides, product identity can
also highlight uncertainties that need further investigation
• Microbials:
• Taxonomy of the microorganism and degree to which it has been identified
• Relatedness to microorganisms that are toxic or pathogenic to humans or nontarget
organisms
• Typical environment in which it is found; conditions that limit growth or presence in the
environment
• Secondary metabolites of concern
• For non-viable microorganisms, marker compounds that might help to quantify the active
ingredient
• Information gleaned from bioinformatics, such as known pathogenicity factors
This Photo by Unknown Author is licensed under CC BY
The Importance of Product Identity
• Biochemicals:
• Chemical identification and composition
• Physical and chemical properties
• Mode of action (non-toxic, by definition)
• Natural occurrence and where it is derived from, already know what is naturally exposed
• Active constituent(s) and/or marker compound for quantification
• Potential for residues
• Can range from purified substances to complex mixtures
This Photo by Unknown Author is licensed under CC BY-NC
Use Patterns and Exposure
• Proposed uses, product formulation, and application methods and equipment can indicate
what exposure may occur
• Proposed uses
• Identifies crops, etc. that the pesticide will be used on
• Determines scope of exposure
• What human populations need consideration (e.g., residential, workers)
• What nontarget organisms need consideration
• Whether exposure through food or feed needs to be considered
• Geographic extent of exposure
• May determine the timing of exposure
• Can include restrictions or indicate human or environmental hazards
Use Patterns and Exposure
• Product formulation
• Intersects with application methods to influence exposure
• Can influence exposure route (e.g., inhalation, dermal)
• Microbial – sensitization to be considered
• Application methods and equipment
• Seed treatment, dips/cuttings – generally lower potential for exposure
• Soil applications – generally lower potential for exposure depending on incorporation
• Broadcast applications of liquids – generally higher potential for exposure
• Other considerations
• PPE
• Engineering controls (enclosed systems)
• Potential for residues
Other Exposure Considerations
• Minimal exposure or lack of exposure is one of the shortest paths to a risk conclusion
• Where some exposure can occur, it is not always easy to quantify for biopesticides
• Biopesticides can consist of complex mixtures
• Microorganisms are alive and population size is influenced by numerous biotic and abiotic factors
• Established environmental fate models are not always adaptable to biopesticides
• Modes of action do not necessarily have a clear dose-response relationship or are easily defined by
levels at which they do or do not occur
• Some questions to ask:
• How quickly does it break down in the environment or begin to have no effect (e.g., no residual effect
after drying)?
• How far beyond the treated area will significant amounts of the pesticide be deposited?
• If applied directly to water at the highest rate, would resulting levels cause effects or exceed natural
levels in the environment?
• What label clarifications would refine the understanding of exposure?
Hazard
• Because of difficulties quantifying some biopesticides, hazard assessment lies at the center of
risk assessment for biopesticides and can be essential to problem formulation
• Studies or other information that demonstrate minimal hazard under worst-case scenarios
leads to conclusions of minimal risk with high confidence ➔ The other shortest pathway to risk
conclusions
• Where hazard and exposure exist, further information may be needed to draw risk conclusions
• Some questions to ask:
• How much hazard data are needed based on product identity information? Is it available?
• If hazard is possible, what is the degree of the effect observed and what information would clarify how
concerning it is (e.g., if effects are observed, but at a low level)?
• Are studies available to discern trends overall or for specific taxa, including studies in the literature?
• What mitigation options are available (e.g., reduced application rate, limitations on use) and are they
feasible?
Example 1 - Microbial Pesticide
• New microbial active ingredient, identified to species though not officially, so limited
information available in the literature
• Intended for use in controlling plant diseases caused by bacteria and fungi
• Taxonomic information indicates potential relatedness to fish pathogen, though literature
indicates that pathogenicity observed primarily in fish farming operations
• Proposed use pattern includes wide variety of crops and spray application to foliar surfaces;
likely to be applied near aquatic areas
• All mammalian data are available, indicating no risk concerns for humans;
an exemption from the requirement of a tolerance is possible
• Nontarget data include guideline studies on a bird, a freshwater fish, and
honeybees; otherwise; data requirements are addressed with scientific
rationale
This Photo by Unknown Author is licensed under CC BY-SA-NC
Example 1 – Microbial Pesticide
• Questions to explore:
• Is the freshwater fish study acceptable and what are the results? Is the species tested appropriate?
• What information can be gained from studies on the related microorganism to understand exposure
levels of concern in aquatic environments?
• Is it possible to reach such exposure levels in aquatic environments given the proposed uses and
application methods?
• Given the reporting in the literature, is it possible to assess the environmental conditions leading to
pathogenicity? If so, are they likely to occur in nature?
• What is the normal environment for the microorganism and its potential to persist outside of it,
including in water?
• Is a study on a marine/estuarine fish needed (i.e., based on the above, are significant amounts
expected in these environments)?
• Is the honeybee study reliable? Are there any reasons why there should be concern for other insects?
• Are the rationales sufficient or, given the lack of information in the literature, is more testing needed?
Example 2 – Biochemical Pesticide
• New biochemical active ingredients, essential oils applied together in a mixture
• Intended for use as an insecticide in a variety of crops; includes residential (home garden) uses;
spray applications on soil only at planting
• Active ingredients present in high concentration in the product
• Some human health data on each active ingredient available in the literature; otherwise, no
mammalian data on some of the active ingredients; addressed with rationale arguing natural
exposure to humans
• Acute toxicity data on the product are available; two dermal irritation studies
on the product indicate it is corrosive
• Tier I nontarget data available on birds and honeybees, no adverse effects
observed; other data requirements addressed with rationale arguing natural
occurrence and nontarget exposure
Example 2 – Biochemical Pesticide
• Questions to explore:
• What human health toxicity data requirements must be addressed, considering use pattern
(food/nonfood), high concentration in the product, and concerns over corrosiveness?
• Is natural exposure sufficient to address toxicity data requirements?
• Are residential uses appropriate, or should the label be restricted? What are other mitigations?
• Where is the source plant normally found; does it have relatives in areas where the pesticide product
will be used, or are the essential oil active constituents found widely in plants?
• Is natural occurrence at background levels a sufficient reason to assume no hazard for all nontarget
taxa?
• Are the available data acceptable and indicative of the potential hazard?
• Is the bee study sufficient to understand effects on insects? Was exposure tested via a relevant route?
Can we understand the mode of action? (If it’s effective as an insecticide, why were there no effects
observed in the bee study?)
• If one assumes potential risk to insects on the treated area, is there sufficient exposure off the treated
area, given the application method? How does application timing affect exposure?
Conclusion
• Biopesticides are generally understood to be of low risk, but problem formulation is key to
establishing a robust risk analysis and arriving at informed risk management decisions
• Product identity can provide key information to guide problem formulation
• The potential for exposure can be clear in some cases, but uncertainties may require greater
reliance on hazard information; clear labeling helps to reduce uncertainty
• A full suite of Tier I hazard data (and higher tiers where necessary) can simplify problem
formulation if no effects are observed; however, problem formulation can identify what data
are actually needed
Thank you!

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The U.S. Perspective on Problem Formulation for Biopesticides: Shannon BORGES

  • 1. The U.S. Perspective on Problem Formulation for Biopesticides PRESENTED AT THE 12 TH EXPERT GROUP ON BIOPESTICIDES SEMINAR: PROBLEM FORMULATION FOR THE RISK ASSESSMENT OF BIOPESTICIDES Shannon Borges, Deputy Director Biopesticides and Pollution Prevention Division Office of Pesticide Programs U.S. Environmental Protection Agency
  • 2. Problem Formulation Basics • Begins with a planning dialog to ensure that the risk assessment enables risk managers to make informed decisions • Define the regulatory action • Establish management or protection goals (e.g., maintaining a sustainable aquatic community) • Determine management options (e.g., restricting uses, requiring specific personal protective equipment) • Determine the preliminary scope and complexity of the risk assessment
  • 3. Problem Formulation Basics • Problem formulation – establishing a foundation for the risk assessment • Integrate available information – how much is available and of what quality • Evaluate the nature of the problem – use patterns, environmental fate, nontarget hazard • Select assessment endpoints – what entity and characteristics of that entity are to be protected • Develop conceptual model – visual depiction of fate in the environment and exposure pathways • Develop an analysis plan – establish risk hypotheses and analyses to test them
  • 4. Starter Questions – Framing the Analysis • Is the biopesticide novel; have we seen something similar or is it completely new? • If not novel (e.g., new strain of a microbial pesticide), what do we know about it already? • What information was submitted from the applicant and are there data gaps? • What is indicated in the scientific literature? • Does it help address any data gaps? • Does it raise additional questions? • What are the hazards indicated, if any? • What are the use patterns and potential routes of exposure? • If risks are identified, what mitigations are available?
  • 5. The Importance of Product Identity • Establishes the foundation for biopesticide problem formulation • Identifies the active ingredient and its defining characteristics • Defines data needs and sets the scope of the analysis • Due to complicated make-up of some microbial and biochemical pesticides, product identity can also highlight uncertainties that need further investigation • Microbials: • Taxonomy of the microorganism and degree to which it has been identified • Relatedness to microorganisms that are toxic or pathogenic to humans or nontarget organisms • Typical environment in which it is found; conditions that limit growth or presence in the environment • Secondary metabolites of concern • For non-viable microorganisms, marker compounds that might help to quantify the active ingredient • Information gleaned from bioinformatics, such as known pathogenicity factors This Photo by Unknown Author is licensed under CC BY
  • 6. The Importance of Product Identity • Biochemicals: • Chemical identification and composition • Physical and chemical properties • Mode of action (non-toxic, by definition) • Natural occurrence and where it is derived from, already know what is naturally exposed • Active constituent(s) and/or marker compound for quantification • Potential for residues • Can range from purified substances to complex mixtures This Photo by Unknown Author is licensed under CC BY-NC
  • 7. Use Patterns and Exposure • Proposed uses, product formulation, and application methods and equipment can indicate what exposure may occur • Proposed uses • Identifies crops, etc. that the pesticide will be used on • Determines scope of exposure • What human populations need consideration (e.g., residential, workers) • What nontarget organisms need consideration • Whether exposure through food or feed needs to be considered • Geographic extent of exposure • May determine the timing of exposure • Can include restrictions or indicate human or environmental hazards
  • 8. Use Patterns and Exposure • Product formulation • Intersects with application methods to influence exposure • Can influence exposure route (e.g., inhalation, dermal) • Microbial – sensitization to be considered • Application methods and equipment • Seed treatment, dips/cuttings – generally lower potential for exposure • Soil applications – generally lower potential for exposure depending on incorporation • Broadcast applications of liquids – generally higher potential for exposure • Other considerations • PPE • Engineering controls (enclosed systems) • Potential for residues
  • 9. Other Exposure Considerations • Minimal exposure or lack of exposure is one of the shortest paths to a risk conclusion • Where some exposure can occur, it is not always easy to quantify for biopesticides • Biopesticides can consist of complex mixtures • Microorganisms are alive and population size is influenced by numerous biotic and abiotic factors • Established environmental fate models are not always adaptable to biopesticides • Modes of action do not necessarily have a clear dose-response relationship or are easily defined by levels at which they do or do not occur • Some questions to ask: • How quickly does it break down in the environment or begin to have no effect (e.g., no residual effect after drying)? • How far beyond the treated area will significant amounts of the pesticide be deposited? • If applied directly to water at the highest rate, would resulting levels cause effects or exceed natural levels in the environment? • What label clarifications would refine the understanding of exposure?
  • 10. Hazard • Because of difficulties quantifying some biopesticides, hazard assessment lies at the center of risk assessment for biopesticides and can be essential to problem formulation • Studies or other information that demonstrate minimal hazard under worst-case scenarios leads to conclusions of minimal risk with high confidence ➔ The other shortest pathway to risk conclusions • Where hazard and exposure exist, further information may be needed to draw risk conclusions • Some questions to ask: • How much hazard data are needed based on product identity information? Is it available? • If hazard is possible, what is the degree of the effect observed and what information would clarify how concerning it is (e.g., if effects are observed, but at a low level)? • Are studies available to discern trends overall or for specific taxa, including studies in the literature? • What mitigation options are available (e.g., reduced application rate, limitations on use) and are they feasible?
  • 11. Example 1 - Microbial Pesticide • New microbial active ingredient, identified to species though not officially, so limited information available in the literature • Intended for use in controlling plant diseases caused by bacteria and fungi • Taxonomic information indicates potential relatedness to fish pathogen, though literature indicates that pathogenicity observed primarily in fish farming operations • Proposed use pattern includes wide variety of crops and spray application to foliar surfaces; likely to be applied near aquatic areas • All mammalian data are available, indicating no risk concerns for humans; an exemption from the requirement of a tolerance is possible • Nontarget data include guideline studies on a bird, a freshwater fish, and honeybees; otherwise; data requirements are addressed with scientific rationale This Photo by Unknown Author is licensed under CC BY-SA-NC
  • 12. Example 1 – Microbial Pesticide • Questions to explore: • Is the freshwater fish study acceptable and what are the results? Is the species tested appropriate? • What information can be gained from studies on the related microorganism to understand exposure levels of concern in aquatic environments? • Is it possible to reach such exposure levels in aquatic environments given the proposed uses and application methods? • Given the reporting in the literature, is it possible to assess the environmental conditions leading to pathogenicity? If so, are they likely to occur in nature? • What is the normal environment for the microorganism and its potential to persist outside of it, including in water? • Is a study on a marine/estuarine fish needed (i.e., based on the above, are significant amounts expected in these environments)? • Is the honeybee study reliable? Are there any reasons why there should be concern for other insects? • Are the rationales sufficient or, given the lack of information in the literature, is more testing needed?
  • 13. Example 2 – Biochemical Pesticide • New biochemical active ingredients, essential oils applied together in a mixture • Intended for use as an insecticide in a variety of crops; includes residential (home garden) uses; spray applications on soil only at planting • Active ingredients present in high concentration in the product • Some human health data on each active ingredient available in the literature; otherwise, no mammalian data on some of the active ingredients; addressed with rationale arguing natural exposure to humans • Acute toxicity data on the product are available; two dermal irritation studies on the product indicate it is corrosive • Tier I nontarget data available on birds and honeybees, no adverse effects observed; other data requirements addressed with rationale arguing natural occurrence and nontarget exposure
  • 14. Example 2 – Biochemical Pesticide • Questions to explore: • What human health toxicity data requirements must be addressed, considering use pattern (food/nonfood), high concentration in the product, and concerns over corrosiveness? • Is natural exposure sufficient to address toxicity data requirements? • Are residential uses appropriate, or should the label be restricted? What are other mitigations? • Where is the source plant normally found; does it have relatives in areas where the pesticide product will be used, or are the essential oil active constituents found widely in plants? • Is natural occurrence at background levels a sufficient reason to assume no hazard for all nontarget taxa? • Are the available data acceptable and indicative of the potential hazard? • Is the bee study sufficient to understand effects on insects? Was exposure tested via a relevant route? Can we understand the mode of action? (If it’s effective as an insecticide, why were there no effects observed in the bee study?) • If one assumes potential risk to insects on the treated area, is there sufficient exposure off the treated area, given the application method? How does application timing affect exposure?
  • 15. Conclusion • Biopesticides are generally understood to be of low risk, but problem formulation is key to establishing a robust risk analysis and arriving at informed risk management decisions • Product identity can provide key information to guide problem formulation • The potential for exposure can be clear in some cases, but uncertainties may require greater reliance on hazard information; clear labeling helps to reduce uncertainty • A full suite of Tier I hazard data (and higher tiers where necessary) can simplify problem formulation if no effects are observed; however, problem formulation can identify what data are actually needed