title: Data disclosure for chemical evaluations.
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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Independent Consultant, Bethesda, Maryland, USA. rwlutter@gmail.com
authors.forename: Randall
authors.initials: R
authors.lastname: Lutter
authors.forename: Craig
authors.initials: C
authors.lastname: Barrow
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Borgert
authors.forename: James W
authors.initials: JW
authors.lastname: Conrad
authors.forename: Debra
authors.initials: D
authors.lastname: Edwards
authors.forename: Allan
authors.initials: A
authors.lastname: Felsot
mesh_terms: D030881:Disclosure; D004785:Environmental Pollutants / Q000633:toxicity; D014481:United States; D014484:United States Environmental Protection Agency
chemical_list: D004785:Environmental Pollutants