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Authors: Kathleen Merrigan, Ph.D., William Lockeretz, Ph.D.

Readings

  • National Research Council. Regulating Pesticides in Food: The Delaney Paradox. Chapter 2 and Appendix A.
  • National Research Council. Pesticides in the Diets of Infants and Children. Executive Summary and Chapter 4. 1993.
  • USEPA. Highlights of the Food Quality Protection Act of 1996.
  • Congressional Research Service. 95016: Pesticide Policy Issues. 1996.
  • Schierow, L.-J. Pesticide Residue Regulation: Analysis of Food Quality Protection Act Implementation. 2002.
  • USEPA. Candidates for Reregistration Decisions. 2003.
  • Code of Federal Regulations. Protection of Environment. pp. 340-343. 2002.
  • USEPA. Captan. 2002.
  • USEPA Office of Pesticide Programs. Summary of Organophosphate Pesticide Usage.

Key Questions

Regulating Pesticides in Food: The Delaney Paradox

  • Which federal agency is involved in pesticide registration?
  • Which federal acts govern pesticide regulation?
  • Why is FIFRA considered a ‘balancing” Act?
  • How do FIFRA and FFDCA differ in regulating pesticides?
  • How do sections 408 and 409 of FFDCA differ in their regulation of pesticides?
  • What are the various steps involved in pesticide regulation?
  • EPA tests each pesticide that is released in the market. T/F?
  • What information is contained on the labels?
  • What is Delaney Clause? Under which Act was this covered?
  • Which section of FFDCA allowed for enforcement of the Delaney Clause?
  • What type of data is required for tolerance setting of pesticides?
  • How are tolerance levels set under sections 408 and 409 of FFDCA?
  • How was Delaney Clause interpreted by the FDA and EPA?
  • How are NOEL and ADI of pesticides calculated?
  • What are the assumptions while deriving ADI?
  • What is the significance of TMRC?
  • What are the assumptions involved in the calculation of TMRC?
  • In most cases, does EPA consider the benefits of pesticides before granting tolerance levels?
  • How is tolerance level set for oncogenic pesticides under section 409 of FFDCA?
  • What is reregistration of pesticides? Why is it done?
  • What is the significance of the constituent policy and de minimis interpretation of the Delaney clause by the FDA?
  • What are the inconsistencies in the present regulatory system according to the authors?
  • Should pesticide residues on raw agricultural commodities and processed foods be regulated based on the same standards?
  • What is the Delaney Paradox?

Pesticides in the Diets of Infants and Children

  • What is meant by qualitative and quantitative differences in toxicity of pesticide between children and adults?
  • What is the limitation in testing protocols which hinders extrapolation of data and information on pesticide toxicity to children?
  • Is the amount of pesticide exposure for children different, when compared to that of adults? If so, why?
  • What is the central thesis of the reading?
  • What are the recommendations of the committee?

Methods for Toxicity Testing: Kids Study

  • What are some of the important factors considered when using animals for setting pesticide tolerances?
  • What is the rate of approval of pesticides by EPA? What is the major reason for rejection?

Highlights of the Food Quality Protection Act of 1996

  • What is the significance of healthbased safety standards for pesticide residue?
  • Are children better protected under the new law?
  • How does the law consider costs and benefits of pesticides?
  • What time frame did FQPA set for reregistration of pesticides?
  • What new information is sought for any new pesticide registration?
  • How does the Act enhance enforcement power of the FDA?
  • What is the role of the states in pesticide regulation?
  • What does the Act propose regarding reregistration and registration renewal of pesticides?
  • What does the Act propose with reference to the categories of safer, minor use and anti-microbial pesticides?

Congressional Research Service

  • What are the main features of PL 104-170, Food Quality Protection Act of 1996?
  • In which sector of the US is the use of pesticide the maximum?
  • For what crops are pesticide applications the maximum?
  • Which agencies are involved in inspecting food and enforcing residue tolerances? How are the responsibilities shared?
  • How is funding made available for pesticide reregistration?
  • According to the EPA, what is one of the major reasons for high costs of reregistration?
  • What are the main issues surrounding the special review of atrazine?
  • How does the EPA respond if a pesticide is found to be hazardous?
  • What conditions would lead to a pesticide being cancelled? How long would this process take?
  • What would happen to the tolerance level established for a pesticide if the pesticide were to be cancelled?
  • What is the reason for the voluntary cancellation of some of the minor use pesticides by the manufacturers? What effect does this have on American agriculture?
  • How does the act support agriculture that is dependent on minor use pesticides?
  • What does Worker Protection Standards (WPS) refer to?
  • Which interest groups support and which oppose WPS enforcement by EPA?
  • Which act governs the export of pesticides from the US?
  • What is the relevance of the Prior Informed Consent (PIC) system to the export of pesticides?
  • Can unregistered pesticides be exported?
  • Should pesticides that are denied registration or reregistration by the EPA be allowed to be exported?
  • Which federal act governs the pesticide residue levels on imported food items?
  • What percentage of agricultural products consumed in the US is imported?
  • What is the FDA’s strategy for inspecting imported food items for pesticide residues? What are the arguments for and against this strategy?
  • How was the Delaney Clause modified under the Act?
  • What are the arguments for and against Federal preemption of states setting up tolerance levels for pesticides?

Pesticide Residue Regulation: Analysis of Food Quality Protection Act Implementation

  • What is the criticism against the EPA despite its stating that the schedule for reregistration of pesticides is being met?
  • How do different stakeholders differ regarding the data that should be considered by the EPA for implementation of the Act?
  • Which group of pesticides has been prioritized by the EPA for reregistration? Why?

Candidates for Reregistration Decisions

What is the difference among the following terms: Reregistration Eligibility Decision (RED), Interim Reregistration Eligibility Decision (IRED) and Tolerance Reassessment Eligibility Decision (TRED)?