EPA Information Quality Guidelines

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EPA Information Quality Guidelines
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Origin of the OMB Guidelines

• 2001 Treasury and General Government
  Appropriations Act (Public Law 106-554) directed
  OMB to issue government-wide guidelines.
• Every federal agency required to develop
  guidelines consistent with OMBs guidance.
• All federal agency guidelines effective by
  10/01/02.

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Overview of OMB GuidelinesAgencies shall

• Adopt a basic standard of quality take steps to
  incorporate guidelines into agency information
  dissemination practices.
• Develop a process for reviewing the quality of
  information before it is disseminated.
• Establish administrative mechanisms for error
  correction.

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Overview of OMB GuidelinesTo whom does it apply?

• Note The Guidelines apply ONLY to federal
  agencies, not to state, local, or private
  organizations.
• The Complication If EPA uses third party data,
  EPA is responsible for ensuring the quality of
  the data meets the intended use.

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Overview of OMB GuidelinesQuality defined

• Objectivity
• Substance Assuring accurate, reliable, and
  unbiased information..based on sound methods
  (reproducibility)
• Presentation in an accurate, clear, complete and
  unbiased manner (proper context, document
  data,methods, assumptions, etc. (transparency))
• Utility
• Usefulness of the information to its intended
  users, including the public
• Integrity
• Protection from unauthorized access or revision
  (security)

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• To what universe of information do the IQGs apply
  ?
• Distributed Information
• Disseminated Information
• Influential Information
• Influential Risk Assessments

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• NOTE The following boxes represent EPA
  information and how the EPA IQG may apply to
  various types of information. This is the first
  in a series of boxes
• All EPA Information
• EPA collects, creates, and retains a vast
• holding of data and information.
• Includes any communication or representation of
  knowledge such as facts or data, in any medium or
  form

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All EPA Information Examples Internal docs

• EPA Distributed Information
• All information that is released
• EPA prepares the info and distributes it to
  support or represent EPAs viewpoint, to
• formulate or to support a possible
  regulation, guidance, other Agency decision,
  position
• EPA distributes information prepared or
  submitted by an outside party in a manner that
• reasonably suggests that EPA endorses or
  agrees with it
• May include instances where EPA reviews and
  comments on information distributed by
• an outside party, or adopts or endorses it.
• Distributions by outside parties are not
  considered to be sponsored by EPA unless
• EPA is essentially using the outside party to
  disseminate information on the Agency's
• behalf
• This box includes information that is not
  covered by guidelines.

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All EPA Information Examples Internal docs
EPA Distributed Information Examples include
press releases, correspondence, public filings,
adjudicative processes

• EPA Disseminated Information
• that is subject to the EPA Information
• Quality Guidelines
• Information that is initiated or sponsored by
  EPA
• Prepared by EPA and used to express a view,
  support a position.
• Information endorsed, adopted, used by EPA
  originating from an external provider.
• Reports, brochures, information supporting
  rules, and non-adjudicative decisions.

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All EPA Information Examples Opinions, internal
docs
EPA Distributed Information Examples include
press releases, correspondence, public filings,
adjudicative processes
EPA Disseminated Information that is subject to
the EPA IQG Examples brochures, fact sheets,
reports
EPA Influential Information OMB Guidelines If an
agency is responsible for disseminating
influential scientific, financial, or statistical
information, agency guidelines shall include a
high degree of transparency about data and
methods to facilitate the reproducibility of such
information by qualified third parties. EPA
Guidelines Information subject to EPA Peer
Review Policy, Top Agency Actions, OMB
Economically Significant actions (100 million
annual impact on economy), Case-by-case
determination EPA will consult with scientific
community to determine what reproducibility
means for different types of original, supporting
data and analytic methods.
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All EPA Information Examples Opinions, internal
docs
EPA Distributed Information Examples include
press releases, correspondence, public filings,
adjudicative processes
EPA Disseminated Information that is subject to
the EPA IQG
EPA Influential Information
EPA Influential Risk Assessments OMB
Guidelines Agencies shall either adopt or adapt
the quality principles of the Safe Drinking
Water Act Amendments of 1996. EPA Draft
Guidelines EPA adapted the SDWA Quality
Principles with minor changes.
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What is not covered by the Draft Guidelines

• Items that are not considered disseminated
• Distribution limited to government employees
• Intra- or inter-agency sharing information
• FOIA, FACA responses
• Distribution of information in correspondence
  with individuals
• Distribution of information via press releases
• Distribution of outdated or superseded
  information
• Distribution of information by recipients of
  contract, grants, or cooperative agreements
  (unless at the direction of EPA)
• Distribution of information via public filings
• Distribution related to subpoenas or adjudicative
  process

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How does EPA ensure and maximize the quality of
disseminated information?

• EPA Quality System (QMPs, QAPPs, assessments)
• External partner Quality Systems
• Review by management
• Peer review process
• The web guide
• Error correction process
• Pre-dissemination reviews

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Pre-dissemination reviews

• Incorporate guideline concepts into existing
  pre-dissemination review procedures.
• Review third party data prior to use.

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How does EPA ensure and maximize the quality of
influential information

• High degree of transparency to facilitate
  reproducibility
• Analytical results have a high degree of
  transparency regarding
• Various assumptions
• Analytical methods employed
• Source of data
• Statistic procedures employed
• If access must be limited (privacy, trade
  secrets, intellectual property, etc) use of
  robustness checks is okay
• Original and supporting data may not be subject
  to the high degree of transparency but we apply
  relevant policies/procedures to achieve
  reproducibility to the extent practicable

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Influential risk assessments

• Adapted the quality principles in SDWA amendments
  of 1996
• To the extent practicable use best available
  science (includes resource time limitations)
  when available
• Weight of evidence approach (peer review best,
  can use other information as well).

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EPA complaint resolution process
What does it apply to? The EPA complaint
resolution process applies to information that is
subject to the guidelines.
EPA Disseminated Information that is subject to
the EPA IQG
EPA Influential Information
EPA Influential Risk Assessments
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Administrative mechanisms for affected persons to
seek and obtain appropriate correction of
information

• Listing of what must be included in a request for
  correction
• Information owner (RA/AA) makes decision
• Reconsideration the appeal

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The appeal process

• Affected person requests appeal
• AA/RA (information owner) presents to 3-member
  panel (AA level members, chair AA for OEI)
• Panel makes final decision on appeal

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Closing thoughts

• Renewed emphasis on quality of data and
  information. There will be a trickle down
  effect to third parties.
• Guidelines do not apply to adjudicative
  information products. Therefore, much of the
  regional work of interest to specific parties is
  not covered. However, other existing quality
  requirements continue to apply.