Food Safety Assessment of Pesticide Residues

The following sections are included:

• Dedication
• Preface
• About the Authors
• List of Tables
• List of Figures
• Contents

The following sections are included:

• Introduction
• Food Safety Initiatives by National, Regional and International Authorities
• Scientific Developments on Chemical Risk Assessment
• The Dietary Risk Assessment of Pesticides
• References

The following sections are included:

• Introduction
• OECD Environment, Health and Safety Programmes
  • OECD Pesticide Programme
  • Harmonization of Data Requirements
  • OECD Series on Principles of GLP
• OECD Test Guideline Programme
• OECD Guidelines and Guidance on Health Effects
  • ADME and Toxicokinetics
  • Acute Toxicity
  • Repeated-Dose Toxicity in Rodents and Non-rodents
  • Carcinogenicity
  • Genotoxicity
  • Reproductive Toxicity and Developmental Toxicity
  • Acute and Repeated-Dose Neurotoxicity and Delayed Neurotoxicity
  • Endocrine Disruption
• OECD Guidelines and Guidance on Pesticide Residues
  • Improved Alignment of Data Interpretation
  • The Livestock Feed Tables
  • The OECD MRL Calculator
• Conclusions on Residues and Future Directions
• References

The following sections are included:

• Introduction
• Data Requirements and Assessment Strategies Common to Australia, the EU and the USA
  • Toxicity Studies
  • Residue Chemistry Studies
    • Residue definitions
    • MRL determinations
• Principles of Safety Assessment of Pesticides — Australia
  • Legal Framework
    • Regulatory history
    • Current regulatory framework
    • Regulatory products
  • Evaluation of Residues
    • Hazard assessment
    • Assessment of residues and dietary exposure
  • Establishing MRLs
  • Export Trade Considerations
  • Dietary Exposure Calculations
  • Public Consultation
  • MRL Enforcement and Monitoring
  • International Activities
• Principles of Safety Assessment of Plant Protection Products — European Union
  • Legal Framework
    • Regulatory history
    • Regulatory framework and regulatory scope
  • Regulatory Processes
    • Approval of pesticide active substances and study requirements
    • Authorization of plant protection products and study requirements
  • Pre-registration Pesticide Dietary Risk Assessment within EU
    • Hazard assessment
    • Pre-registration residue assessment
    • Pre-registration dietary risk assessment
  • MRL Setting and Import Tolerances
  • MRL Enforcement and Monitoring
  • Future Developments
• Principles of Safety Assessment of Pesticides — United States of America
  • Regulatory Background
  • Registration Process
  • Hazard Assessment
    • Hazard characterization and toxicity profile
    • Endpoint selection
    • Point-of-departure selection and uncertainty factors
  • Residue Chemistry Evaluation
    • Residue definitions
    • MRL determinations
    • Exposure and risk assessment
  • Enforcement and Monitoring
  • Harmonization with Other Regulatory Authorities
• References

The following sections are included:

• Introduction
• Residue Evaluation
  • History of JMPR Residue Evaluation
  • Metabolism and Environmental Fate
    • Livestock metabolism
    • Crop metabolism
    • Environmental fate
    • Aerobic soil metabolism
    • Residues in rotational crops
  • Residue Analysis, Sampling and Sample Storage
  • Residue Definition
  • Use Pattern
  • Supervised Residue Trials
    • The minor crop problem
    • Spices
  • Food Processing
  • Livestock and Residues in Meat, Eggs and Milk
  • Monitoring Data, EMRLs
• Toxicological Evaluation
  • Data Requirements for Toxicological Evaluation
    • Toxicity data used for toxicological evaluation
  • Importance of Quality and Reliability Control of Toxicity Data
    • Compliance with quality principles
    • Accordance to OECD test guidelines
    • Quality, relevance and utility of published studies
  • Main Endpoints for Toxicological Evaluation
    • ADME study and kinetics
    • Acute toxicity, irritation and sensitization
    • Short-term toxicity
    • Long-term toxicity and carcinogenicity
    • Genotoxicity study
    • Reproductive and developmental toxicity studies
    • Reproductive toxicity study
    • Developmental toxicity study
    • Neurotoxicity
    • Immunotoxicity
    • Human and epidemiologic data
    • Mechanistic data
  • Considerations on Plant and Animal Metabolites
    • Process of toxicological evaluation in risk assessment
    • Toxicological significance of species specific lesion
  • Current Topics of Toxicological Evaluation of Chemicals
    • 3R principles
    • Future methodology for toxicological evaluation of pesticides
  • Conclusions and Future Directions
• References

The following sections are included:

• Introduction
• Pre-requisites of Pesticide Residue Assessment Approaches to Food Consumption Data Collection
  • Long-term Exposure (see also Chapter 6 )
  • Short-term Exposure (see also Chapter 6 )
  • Statistical Considerations
• Food Consumption Data Collection Instruments and Methods
  • Sources of National Food Data
  • National Food Consumption Surveys
  • Dietary Recalls
  • Food Records
  • Administration of the Data Collection
  • Portion Size Estimation
  • Special Considerations in Relation to Data Collection with Reference to Pesticide Residue Assessment
  • Food Information
    • Food Classification and Description Systems
    • Handling of Composite Foods
    • Conversion Factors for Consumed Foods to Raw Agricultural Commodities
  • Study Organization
    • Survey Organization and Planning Phase
    • Sampling
    • Sample Size
    • Supporting Non-dietary Survey Data
    • Quality Assurance
  • Data Cleaning and Handling
  • Reporting of Food Consumption Data
  • Total Diet Studies
  • Future Challenges of Food Consumption Survey Data Collections
• References

The following sections are included:

• Introduction
• Food Consumption Data
  • The GEMS/Food Diets
  • Food Consumption Data for Long-term Dietary Exposure Estimates
  • Food Consumption Data for Short-term Dietary Exposure Estimates
• Pesticide Residue Data
  • Pre-registration Residue Data
  • Post-registration Residue Data
    • Residue data obtained by monitoring programmes
    • Residue data obtained from total diet studies
    • Residue data obtained from duplicate diet studies
  • Deterministic and Probabilistic Approaches to Estimate Dietary Exposure to Pesticides
    • Long-term and Short-term Dietary Exposure
      • Long-term dietary exposure
      • Less-than-lifetime exposures
      • Short-term Dietary Exposure
    • Cumulative and Aggregate Exposure
  • Harmonization of International Dietary Exposure Assessment
  • Risk Characterization of Pesticide Residues in Food
    • Compounds with ADI and/or ARfD
    • TTC Approach
• References

The following sections are included:

• What is the Codex Alimentarius Commission?
  • Importance of the Codex Alimentarius Commission (CAC) in Food Safety in Relation to the International Food Trade
  • Statutes of the CAC
  • Structure of the CAC
  • Role of Science and Risk Analysis in the CAC
• Establishment of Codex Maximum Residue Limits (MRLs) for Pesticides, Extraneous Maximum Residue Limits (EMRLs) and Related Recommendations
  • Codex Definitions of the Terms Related to Pesticide Residues
  • Codex Committee on Pesticide Residues
  • Criteria for Initiating Work on Codex Recommendations Related to Food Safety
    • General criteria
    • Selection of pesticides for which MRLs and EMRLs need to be developed
    • Procedures for Elaborating the MRL and EMRL and Other Recommendations
    • Expression and Specific Issues of MRLs and EMRLs
  • Codex Recommendations Related to Pesticide Residues in Foods and Feeds Other than MRLs and EMRLs
• References

The following sections are included:

• Introduction
• History
  • Origins of JMPS and Its History
  • Origins of CIPAC and Its History
• CIPAC Methods
  • CIPAC Methods for the Determination of the Active Ingredient Content
    • Use of the methods
  • Methods for Relevant Impurities
• Technical Materials
  • Technical Material: Identity
  • Technical Materials: Purity
  • Impurities in Technical Materials
  • Impurity Names
  • Expression of Relevant Impurities
    • Glyphosate Example (FAO, 2001)
  • Reference Material
    • Composition of the reference profile
• Formulations
  • Water as a Relevant Impurity
  • Relevant Impurities and Intended Use
• Equivalence
• Physical Properties
  • Acidity and pH Range
  • Persistent Foam
  • Dustiness
  • Wet Sieve Test
  • Suspensibility
  • Pourability
  • Attrition Resistance
• Storage Stability
  • Storage Stability at Elevated Temperature
• Future Directions
• References

The following sections are included:

• Introduction
• Sampling Terminology
• Decision Unit (Lot, Population)
• Mass Reduction
• Representative Sample
• Sampling Correctness
• Material Properties and Sampling Dimensions
  • Finite Element Materials
  • Infinite Element or Bulk Materials
  • Sampling Dimensions
  • Zero-Dimensional Sampling Model
  • One-Dimensional Sampling Model
  • Two-Dimensional Sampling Model
  • Three-Dimensional Sampling Model
  • Packaged Foods in Commerce: Finite or Infinite?
• Pierre Gy’s Theory of Sampling
  • Heterogeneity: Degree to Which a Material is Not Homogeneous
  • Compositional Heterogeneity: Variability in Composition
  • Control Fundamental Sampling Error by Collecting Sufficient Mass and Reduce Particle Size
  • Sampling Constant Varies Greatly in Different Materials
  • Are We Collecting Sufficient Sample Mass?
  • Distributional Heterogeneity is the Spatial and Temporal Relationship between Elements
  • Control GSE by Collecting Sufficient Mass and More Increments
  • Equal Probability of Selection
• Sampling Techniques — Striving to be Representative
  • Randomness
  • Zero-Dimensional Sampling
  • Systematic Random Sampling
  • One-Dimensional Systematic Sampling
  • Nugget Effect
  • Two-Dimensional Sampling with Tools
  • Center of Gravity Rule
  • Three-Dimensional Sampling and Mass Reduction
• Correct vs. Incorrect Sampling
  • Why, Where, What and When?
• Combined Estimation of Errors
  • Sources of Sampling Error
• Laboratory Sampling Errors
  • Dividing the Sample
  • Sample Preparation and Processing
• Pesticide Residue Sampling Research
  • Collect 10 Increments per Sample ?
  • Pesticide Residues Skewed Distribution and Variability Factors
  • Estimates of Minimum Mass
  • Call for Identification of Factors Affecting Uncertainty
  • No Generic Sampling Plan Can Be Recommended
  • Large Field to Field Variability due to Soil, Weather, Environment and Application Methods
  • Twenty-Five Increments per Sample Provides More Normal Distribution of Average Residues
  • Uncertainty for Enforcing MRLs Increased by 1.2 vs Field Trial Data
  • Protocols should be Different for Before Market Acceptance and After Market Enforcement
  • GMO and Seed Sampling
• Standardized Sampling Guidelines
  • Integration of TOS and MU
  • Sample Integrity
  • Sampling Animal Tissue and Animal Products
  • Sampling for MRL Development and Enforcement
  • Codex Guidelines
  • Commodity Portion Sampled for MRL Enforcement
• Management Responsibilities
• References

The following sections are included:

• Introduction
• Factors Affecting the Results of Pesticide Residue Analysis
  • Variability of Pesticide Residues within Fields
  • Sources and Calculation of Uncertainty of Measured Residue Concentrations
  • Characterization of the Distribution of Pesticide Residues
• Estimation of Sampling Uncertainty
  • Methods for Estimation of Uncertainty of Sampling
  • Databases Used for Estimation of Uncertainty of Sampling for Pesticide Residue Analysis
• Estimation of Sampling Uncertainty Based on Primary Samples
  • Effect of Sample Size (n) and Number of Replicate Samples (p) on Accuracy and Variability of Estimated Average Residue
  • Effect of Variability of Residues in the Decision Unit (Sampling Target)
  • Effect of Number of Lots Sampled and Replicate Samples Taken
• Estimation of Sampling Uncertainty Based on the Results of Supervised Trials
  • Calculation of Sampling Uncertainty from Replicate Composite Samples
  • Calculation of Confidence Limits
  • Factors Affecting the Estimated Sampling Uncertainty
  • Sampling Uncertainty Values Estimated for Crops and Crop Groups
  • Practical Use of the Estimated Sampling Uncertainties
• Summary of Sampling Uncertainty for Pesticide Residue Analysis
  • Methods for the Estimation of Sampling Uncertainty
  • Effect of Sample Size on the Uncertainty of Sampling
  • How Many Lots to be Tested and How Many Samples To Be Taken?
  • Preconditions for Making Reliable Decisions based on Uncertainty of Sampling
• Effect of Handling of Laboratory Samples on the Accuracy and Uncertainty of the Results of Analyses
  • Sources of Bias
  • Variability of Residues in Processed Samples
• Uncertainty and Trueness of Analysis of Residues in Test Portions
  • Basic Rules of Propagation of Error
  • Examples
• Quality Control of the Determination of Pesticide Residues
  • Sampling
  • Sample Processing and Analysis
• Use of Combined Uncertainty of Measured Residues to Verify Compliance with MRLs and Settling Disputes
• References

The following sections are included:

• Introduction
• Examples for Involvement of Small-Scale Farms in the Production of Fruits and Vegetables
  • Initiative of a Small-Scale Farm in South-East Asia
  • Family Farm with Own Packing and Exporting Capability in Combination with Contractual Agreement with Other Fruit Growers in South America
  • Growers’ Volunteer Cooperation in a European Country
  • Exporter’s Business Enterprise with Extended Advisory and Raw Material Supply Chain in Africa
  • Exporters Deal with Contracted Farmers in Africa
• Theoretical Background for Elaboration of Risk-Based Monitoring Programmes
  • Field to Field Distribution of Pesticide Residues
  • Calculation of the Probability of Violation of MRLs
  • Estimation of the 97.5th percentile of Residues in Crops Treated with a Pesticide
• Principles of Control of Chemical Substances in Food
• Tiered Model for Planning Monitoring Programmes
• Practical Application of Tiered Model
  • Tier 1: Data are Available from Supervised Trials, But There is No Monitoring Data (Steps 1 and 3)
  • Tier 2: Monitoring Data and Established MRL are Available
  • Evaluation of a Pesticide Shortly After Registration
• Number of Samples to be Included in Future Monitoring Programmes
• Conclusions and Recommendations
• References

When we look to past history as a guide to the future, we see steady scientific and administrative progress in the practices related to assessment and control of pesticide residues in food. But we also see that, from time to time, the steady progress is punctuated by public controversies about residues in food that have stimulated special responses by government and industries.

The following sections is included:

• Index