Data Disclosure for Chemical Evaluations

Randall Lutter,¹ Craig Barrow,² Christopher J. Borgert,³ James W. Conrad Jr.,⁴ Debra Edwards,⁵ and Allan Felsot⁶


¹Independent Consultant, Bethesda, Maryland, USA; ²Craig Barrow Consulting, Gibsonia, Pennsylvania, USA; ³Applied Pharmacology and Toxicology Inc., Gainesville, Florida, USA; ⁴Conrad Law & Policy Counsel, Washington, DC, USA; ⁵Independent Consultant, Alexandria, Virginia, USA; ⁶Food and Environmental Quality Lab, Washington State University, Richland, Washington, USA


Abstract

Background: Public disclosure of scientific data used by the government to make regulatory decisions for chemicals is a practical step that can enhance public confidence in the scientific basis of such decisions.


Objectives: We reviewed the U.S. Environmental Protection Agency’s (EPA) current practices regarding disclosure of data underlying regulatory and policy decisions involving chemicals, including pesticides. We sought to identify additional opportunities for the U.S. EPA to disclose data and, more generally, to promote broad access to data it uses, regardless of origin.


Discussion: We recommend that when the U.S. EPA proposes a regulatory determination or other policy decision that relies on scientific research, it should provide sufficient underlying raw data and information about methods to enable reanalysis and attempts to independently reproduce the work, including the sensitivity of results to alternative analyses. This recommendation applies regardless of who conducted the work. If the U.S. EPA is unable to provide such transparency, it should state whether it had full access to all underlying data and methods. A timely version of submitted data cleared of information about confidential business matters and personal privacy should fully meet the standards of transparency described below, including public access sufficient for others to undertake an independent reanalysis.


Conclusion: Reliable chemical evaluation is essential for protecting public health and the environment and for ensuring availability of useful chemicals under appropriate conditions. Permitting qualified researchers to endeavor to independently reproduce the analyses used in regulatory determinations of pesticides and other chemicals would increase confidence in the scientific basis of such determinations.


Key words: chemicals, data disclosure, information quality, pesticides. 


Environ Health Perspect 121:145–148 (2013). http://dx.doi.org/10.1289/ehp.1204942 [Online 11 December 2012]


Address correspondence to R. Lutter, 5024 Newport Ave., Bethesda, MD 20816 USA. Telephone: (240) 271-8430. E-mail: rwlutter@gmail.com


This commentary is based in part on discussions that occurred during a meeting convened by CropLife America on 13 May 2011, in Washington, DC. Participants in the meeting included the authors of this work and the following experts, whose helpful comments we gratefully acknowledge: V. Dellarco (U.S. Environmental Protection Agency), D. Epstein (U.S. Department of Agriculture), M. Fry (American Bird Conservancy), G. Gray (George Washington University), S. Krimsky (Tufts University), J. McFarland (Syngenta Crop Protection Inc.), J. Sass (Natural Resources Defense Council), and J. Schroeder (New Mexico State University). 


The views expressed in this document are entirely those of the authors and not necessarily those of any organization(s) with which any author is affiliated.


R.L., an independent consultant, consults for CropLife America (CLA) and received financial support from the CLA to moderate a forum and serve as principal author of this paper. C.B. consults for Dow AgroSciences LLC, an R&D-based agrochemical producer, registrant, and marketer. C.J.B. received CLA funding to review and analyze scientific literature on data quality. J.W.C. has previously received funding from the American Chemistry Council to author work on the quality of scientific research evaluating chemicals. D.E. consults for a variety of pesticide manufacturers and for the CLA. A.F. has consulted with nonprofit organizations funded by the CLA about pesticide issues.


Received 9 January 2012; Accepted 5 December 2012; Online 11 December 2012.