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Considerations for
Problem Formulation
for Human Health
Safety Assessments of
Biopesticides
Leah Zorrilla, Ph.D.
Bayer Crop Science
On behalf of Crop Life International
2) Establish criteria on how to address human safety
areas of potential concern via problem formulation:
- Is the natural substance a potential human pathogen?
- Is the natural substance capable of causing infection?
- Does the natural substance have toxic or genotoxic
properties?
- Does the natural substance have the capability to
produce clinically relevant antibiotics or contain
clinically relevant antibiotic resistance markers?
1) Use a specific strategy suited to the unique
characteristics of biopesticides (not using
irrelevant small molecule or protein strategies
or guidelines)
4) Limit the number of pathogenicity studies
(prioritize routes of administration based on
human exposure)
3) Use relevant new approach methodologies
(NAMs) or whole genome sequencing (WGS;
sequence identity with genomic actors of
concern) where possible to avoid unnecessary
animal studies because of outdated testing
strategies
Human Safety Assessments for Biopesticides should:
Goal: Globally
Harmonized
strategy to
evaluate
biopesticides
2
What are we doing and why?
Human Safety Evaluations for Biopesticides
Evaluation/Testing Strategy
Whole Genome
Sequencing (WGS)
Literature
Reviews
Acute Studies
Pathogenicity Studies
What Value Add
Evaluations of relevant and reliable (current –10
years) toxicity, pathogenicity or regulatory
information in public literature on genus/species.
Allows consideration of what additional
information or regulatory questions that may
come up during registration processes. Can help
with early identification of higher risk microbes.
Genome sequence evaluated for ability of
microbe to produce biological chemistries of
toxicological concern, genotoxicants, clinically-
relevant antibiotics, antibiotic resistance markers,
pathogen potential for bees.
Supports prioritization, addressing genes of
potential concern to manage for regulatory
purposes. This evaluation can significantly reduce
or eliminate need for animal studies.
Usually, confirmatory study (studies) based on the
WGS. These studies are resource and animal
intensive and do not add (much) value to human
risk assessment, as they are largely showing no
adverse effects.
Important for labeling purposes, however, CLP
calculation method could be used in lieu of animal
studies: no validated test method for skin
sensitization, work to be done on validation of
eye/skin irritation alternative methods.
Requirements on both “active ingredient/whole
broth” and formulated products to support
classification and labeling.
Evaluates the potential of a microbe to multiply
and cause infections in tissues throughout the
animal; each route of administration (oral, dermal,
inhalation, ip/iv injection) can be required in some
regions.
/// Zorrilla OECD BPSG Seminar// February 26 2024
In Summary……
Data needs to be generated to determine foreseeable risks for these unique
types of agriculture solutions.
Currently studies are focused on potential for pathogenicity, infectivity,
toxicity; however, these studies do not answer all of the questions
associated with identifying hazards for human safety.
Understanding the potential secondary metabolites is equally important.
Tools are available to assess hazards using WGS; building and
validation of databases containing all sequences with potential
hazards/genomic actors of concern need be developed, consistently
updated (similar to COMPARE Allergen database for proteins) and
widely available.
Validation efforts for NAMs for skin and eye irritation, and perhaps inhalation
could also be a focused effort to eliminate these testing requirements.
Finally, global harmonization of biopesticide testing strategies is critical to reduce
the in vivo tests to allow for more accurate predictions of potential human risk.
Problem Formulation for Human Health Safety Assessments of Biopesticides
4 /// Zorrilla OECD BPSG Seminar// February 26 2024
///////////
Thank you!
Special Thank You to Bayer
Colleagues: Lisa Ortego, Nico
Visconti, Hanno Bothe, Elizabeth
Webb, Greg Watson

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Considerations for Problem Formulation for Human Health Safety Assessments of Biopesticides: Leah Zorrilla

  • 1. /////////// Considerations for Problem Formulation for Human Health Safety Assessments of Biopesticides Leah Zorrilla, Ph.D. Bayer Crop Science On behalf of Crop Life International
  • 2. 2) Establish criteria on how to address human safety areas of potential concern via problem formulation: - Is the natural substance a potential human pathogen? - Is the natural substance capable of causing infection? - Does the natural substance have toxic or genotoxic properties? - Does the natural substance have the capability to produce clinically relevant antibiotics or contain clinically relevant antibiotic resistance markers? 1) Use a specific strategy suited to the unique characteristics of biopesticides (not using irrelevant small molecule or protein strategies or guidelines) 4) Limit the number of pathogenicity studies (prioritize routes of administration based on human exposure) 3) Use relevant new approach methodologies (NAMs) or whole genome sequencing (WGS; sequence identity with genomic actors of concern) where possible to avoid unnecessary animal studies because of outdated testing strategies Human Safety Assessments for Biopesticides should: Goal: Globally Harmonized strategy to evaluate biopesticides 2
  • 3. What are we doing and why? Human Safety Evaluations for Biopesticides Evaluation/Testing Strategy Whole Genome Sequencing (WGS) Literature Reviews Acute Studies Pathogenicity Studies What Value Add Evaluations of relevant and reliable (current –10 years) toxicity, pathogenicity or regulatory information in public literature on genus/species. Allows consideration of what additional information or regulatory questions that may come up during registration processes. Can help with early identification of higher risk microbes. Genome sequence evaluated for ability of microbe to produce biological chemistries of toxicological concern, genotoxicants, clinically- relevant antibiotics, antibiotic resistance markers, pathogen potential for bees. Supports prioritization, addressing genes of potential concern to manage for regulatory purposes. This evaluation can significantly reduce or eliminate need for animal studies. Usually, confirmatory study (studies) based on the WGS. These studies are resource and animal intensive and do not add (much) value to human risk assessment, as they are largely showing no adverse effects. Important for labeling purposes, however, CLP calculation method could be used in lieu of animal studies: no validated test method for skin sensitization, work to be done on validation of eye/skin irritation alternative methods. Requirements on both “active ingredient/whole broth” and formulated products to support classification and labeling. Evaluates the potential of a microbe to multiply and cause infections in tissues throughout the animal; each route of administration (oral, dermal, inhalation, ip/iv injection) can be required in some regions. /// Zorrilla OECD BPSG Seminar// February 26 2024
  • 4. In Summary…… Data needs to be generated to determine foreseeable risks for these unique types of agriculture solutions. Currently studies are focused on potential for pathogenicity, infectivity, toxicity; however, these studies do not answer all of the questions associated with identifying hazards for human safety. Understanding the potential secondary metabolites is equally important. Tools are available to assess hazards using WGS; building and validation of databases containing all sequences with potential hazards/genomic actors of concern need be developed, consistently updated (similar to COMPARE Allergen database for proteins) and widely available. Validation efforts for NAMs for skin and eye irritation, and perhaps inhalation could also be a focused effort to eliminate these testing requirements. Finally, global harmonization of biopesticide testing strategies is critical to reduce the in vivo tests to allow for more accurate predictions of potential human risk. Problem Formulation for Human Health Safety Assessments of Biopesticides 4 /// Zorrilla OECD BPSG Seminar// February 26 2024
  • 5. /////////// Thank you! Special Thank You to Bayer Colleagues: Lisa Ortego, Nico Visconti, Hanno Bothe, Elizabeth Webb, Greg Watson