EC Pharmacology and Toxicology

In order to register pesticides their safety to humans must be supported by a battery of animal toxicity studies. As submitted, the study reports can contain the biases of the study authors and sponsors. Thus, they are critically reviewed by toxicologists within governmental regulatory agencies. Often the reviews by one country’s regulatory agency are used by third parties. Within the United States, the review of these toxicology studies is the responsibility of the Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP). The procedure that OPP currently uses consists of preparing Data Evaluation Records (DERs) that have multi levels of reviewers. The DER formats for each study type are firmly set so that nearly all of their content has to be transcribed from the study report into the DER. In preparing the DER, the reviewers make their own tables for responses to treatment and in doing so they can be biased in selecting data based on their interpretations. This means that third parties see a secondhand account of the study containing the biases of the reviewers. In order to address this problem, it is proposed that standardized formats for each study type be designed by the regulatory agencies that will contain the critical study information so that it does not have to be transcribed. The reviewers will complete a table of concurrence/nonconcurrence for all of the critical aspects of each study type. They would make data tables only when they do not concur with the study report. The resulting review product will allow third parties to see the interpretation of the study as determined by the study authors as well as by the reviewers and can determine the significance of biases.

 Keywords: Animal Toxicity; Pesticide; Environmental Protection Agency (EPA); Office of Pesticide Programs (OPP); Data Evaluation Records (DERs)

1. These records, including over 4500 recently released documents covering toxicology, chemistry, and environmental fate are publicly available in Chem View.
2. FIFRA: United States Code of Federal Regulations 40 CFR Part 158. Data Requirements for Pesticides.