which partitioning processes do not occur. The studies can provide useful information on the long-term effects of a formulation as it is applied, but these exposures probably have little relevance to exposures that occur in the environment as environmental partitioning occurs.

In some cases—for example, the Roundup formulations of glyphosate (EPA 2008)—detailed information is available on the toxicity of an active ingredient, the toxicity of specific inerts, and the toxicity of a formulation. In such cases, more detailed assessments can be conducted on the basis of analyses of toxic interactions or available data on the mixture of concern.


Another problem that arises in using formulation studies to assess the toxicity of inerts in pesticide formulations concerns “data-bridging.” Although EPA generally requires at least acute toxicity data on pesticide formulations, it will often allow toxicity studies on one formulation to support the registration of another. That general approach is sometimes referred to as bridging registration (EPA 2012f). Data-bridging is used in the United States (EPA 2002, 2012f) and member nations of the Organisation for Economic Co-operation and Development (OECD 2001). Although data-bridging is motivated by economic factors (reducing the costs associated with pesticide registration) and ethical factors (reducing the number of animals that must be used in toxicity studies), the process of data-bridging must be supported by similarities between the two formulations to be scientifically credible.

The committee concurs that data-bridging is sensible if two formulations are identical (the same formulation marketed under different names). If two formulations are substantially different, however, formulation-specific data are required. Recently, EPA (2012g) released relatively detailed guidance for waiving mammalian acute toxicity studies. Although the document is titled Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides and Pesticide Products, the main focus concerns the criteria for waiving acute toxicity studies rather than for bridging data among formulations. The OECD guidelines (OECD 2001, p. 89ff) articulate bridging principles that are generally consistent with EPA’s approach to assessing sufficient similarity. However, formulation-bridging is not transparent. In the absence of information, uncertainty can lead to assumptions that are not justified.

Foreign Formulations

Information is sometimes available on the toxicity of pesticide formulations used outside the United States. If comparable information is available on the US and foreign formulations, the information on the US formulation should take precedence because it will be the most applicable. If information is not available on the US formulation, the relevance and utility of the information on

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement