The Importance of Access to Underlying Data Ann Mason December 10, - - PowerPoint PPT Presentation

The Importance of Access to Underlying Data

Ann Mason

December 10, 2013 Society for Risk Analysis Annual Meeting, Baltimore, Maryland

So Why is Access to Data Important?

• Validity and quality of findings
• Statistics and correlations
• Comparison to other studies

Currently:

• Underlying data might be available as supplemental information

to journal; but not uniformly available

• EPA requesting raw data from some authors but not all for IRIS

assessments

• Databases on exposure are limited

The Need for Access to Underlying Data

• Scientific & research studies are used as foundation for

policy & regulatory decisions

• Governmental Characterizations and Assessments:
• EPA’s Integrated Risk Information System (IRIS) is a database of

cancer and non-cancer toxicity criteria for use within EPA

• The National Toxicology Program (NTP) Report on Carcinogens

reports agents and substances “known” or “reasonably anticipated” to cause cancer in humans

• The Agency for Toxic Substances and Disease Registry (ATSDR)

has a database of hazard values for non cancer effects

• States frequently develop their own hazard values
• Regulatory standards
• Product safety
• Workplace protections

Why Need Data?

Example 1: Clarify Dose : Exposure Relationship

Blood Chemistry

Observed Effects EPA Used Paper as Evidence of Critical Pathway for Effects in IRIS Assessment Effects from disease or chemical exposure?

Exposure

Individual Personal Monitors FOIA to access exposure

data

Federally- Funded Epidemiology Study as basis for MOA Hypothesis

Why Need Data? Example 2: Replicate Data Analysis

Effects

Reported Cancer Effects EPA Used Papers as Evidence of Adverse Effects in IRIS Assessment

Exposure

Groups: Peak Exposure? FOIA to access data Data grouped to prevent subject identity Technology transfer agreement

Federally- Funded Human Cohort Study as basis for IRIS risk values

Why Need Data? Example 3: Develop PBPK Model

Bioassay

Gov-funded bioassay reported cancer effects

• Agency shared slides

for pathology evaluation

EPA & States Assumed Linearity in Assessments

MOA Study

MOA study to Identify Key Events Publications included Data Supplements Raw data submitted to regulations.gov Data and model shared with EPA Will agencies use data?

Industry Funded Mode of Action Study

Summary

• Governmental assessments establish toxicity criteria to derive

“safe” levels -- input into regulatory standards; used by other agencies’

• Access to federally-funded raw data used in governmental

assessments are difficult (nearly impossible) to obtain

• FOIA access: data grouping prevents/limits reanalysis
• Access to raw data needed to answer/clarify key questions:
• Dose response
• Causality
• Uncertainties and the need to apply assumptions

The Need for Access to Underlying Data

• Shelby Amendment (1998) (Public Law 105-277)
• Directed OMB to amend Circular A-110 “to ensure that all data

produced under an award will be made available to the public through the procedures established under the Freedom of Information Act”

• Revised OMB Circular A-110 (1999)
• Limited to:
• Published research findings (journal)
• Used to support agency action that has “force and effect of law”

(rule, regulation)

• Excludes:
• Data never published or cited
• Data used in formulating risk assessments or guidelines