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.
- Staff Background Paper #5.1. 1998.
- TEMIK Brand 10G Aldicarb Pesticide Label.
- MDAR website. http://www.mass.gov/agr/about/index.htm. Jan. 2006.
- Croplife America website. http://www.croplife.org/. Jan. 2006.
- Beyond Pesticides website. http://www.beyondpesticides.org/. Jan. 2006.

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)?

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