Theme #4:  Protection of the 'public interest' (constitutional protection of individuals' inherent right to 'due process of law') in an era of expanding international regulatory cooperation depends on the establishment, maintenance and oversight of mutually transparent risk-based best available science ("BAS") and economic cost-benefit-analysis-driven government regulatory and technical standards regimes that assure meaningful public participation and input.  These regimes must provide public notice and comment mechanisms of sufficient duration prior to agency adoption of final rulemakings, and must offer adequate data/information quality review mechanisms to ensure the validity and reliability of agency and third-party-generated science & technical data/information prior to government dissemination and use of it as the bases for agency decision-making, including economically significant rulemakings and administrative enforcement actions.

ITSSD professional staff and Board of Advisors members have been integrally involved and possess expertise in scientific risk assessment and risk management, scientific peer review, environmental, health and safety law and regulatory science policy and atmospheric pollution metrics.  This experience spans the fields of chemistry, biology, toxicology, pharmacology, physics and mathematics, engineering and computer simulations of atmospheric pollution, etc.

For example, during 2009, 2011 and 2012, members of ITSSD's professional staff and/or Board of Advisors submitted oral and written testimony before Congress regarding the need for transparency of the processes EPA uses in performing peer review and formulating regulations based on agency science (Moghissi, McBride).  During 2011, one member of the ITSSD Board of Advisors submitted oral and written testimony before Congress regarding the need to separate risk assessment, a primarily scientific undertaking, from risk management, a more policy-related undertaking (Marchant).  During 2006, several members of the ITSSD Board of Advisors submitted written comments to the Office of Management and Budget's Office of Information and Regulatory Affairs in response to a federal register notice soliciting public comments on OMB's then proposed risk assessment bulletin (Moghissi, McBride).  During 2013, at least one member of the ITSSD Board of Advisors participated in public seminars discussing the potential impact of climate change on public health (McBride).  During 2010, 2012 and 2013, several members of the ITSSD Board of Advisors authored books on risk assessment, peer review and metrics for evaluating and validating scientific claims (Moghissi, Straja), while at least one such member has served as editor-in-chief of several prestigious peer reviewed scientific journals (Straja).  During 2013, one ITSSD professional staff member and a member of the ITSSD Board of Advisors separately analyzed and reached clearly conveyed findings concerning the potential downstream domestic and international scientific, legal and economic impacts of the federal government potentially pursuing policy-based science in lieu of science-based policy with respect to risk assessment and risk management protocols (Kogan, Moghissi). During 2014, this professional staff member's contribution to the public understanding of these issues in the ongoing EU-U.S. Transatlantic Trade and Investment Partnership ("TTIP") negotiations was recognized by this administration, the European Parliament, the European Commission, and the New York-based Burton Foundation.

Most of these documents are publicly accessible as set forth below:

​ITSSD Programs - Theme #4 (2006-2013)

International Regulatory Transparency

ITSSD IQA SCOTUS Brief & Peer Review Expertise

ITSSD Board of Advisor Comments on Office of Management and Budget, Office of Information and Regulatory Affairs, Proposed Risk Assessment Bulletin (2006)

A. Alan Moghissi, Dennis K. McBride, Sorin R. Straja et al., Risk Analysis Center Response to Office of Management and Budget Proposed Risk Assessment Bulletin, Risk Analysis Center (Institute for Regulatory Science & Potomac Institute for Policy Studies) (June 2006).   All public comments available here.

ITSSD Board of Advisor Publication - (2011) - A. Alan Moghissi and Misti Ault Anderson, Independent Peer Review of Regulatory Science Information, Institute for Regulatory Science (June 2011).   

Abstract - "This manual describes the independent peer review processes developed by the Institute for Regulatory Science (RSI) that support regulatory science activities conducted by government agencies at the federal, state, regional or local levels; various segments of industry; and other organizations.  Consistent with the historic tradition of science, the RSI peer-review process provides an unbiased, independent, economical, and timely response to those organizations needing support on specific actions related to regulatory science."

ITSSD Board of Advisor Publication - (2012) - A. Alan Moghissi, et al., Ruckelshaus Effect, Synesis: A Journal of Science, Technology, Ethics & Policy (Potomac Institute Press 2012)

Abstract: The role of experts in society, from ancient philosophers to contemporary scientific advisors has been debated since antiquity.  The founder of the EPA, William Ruckelshaus, argued that the role of scientists in society is to address only scientific issues.  This paper provides the seven principles that are the foundation of Ruckelshaus Effect.  It also describes direct and indirect consequences of Ruckelshaus Effect including the Evolution of Best Available Science (BAS) and Metrics for Evaluation of Scientific Claims (MESC) derived from it that are based on five principles (open-mindedness, skepticism, universal scientific principles, transparency, and reproducibility) and include three pillars (reliability standardization of science in terms of its maturity, and areas outside the purview of science).  This paper also addresses the relationship between the Ruckelshaus Effect, risk analysis (assessment, management and communication), and the evolution of regulatory science as a new scientific discipline.

ITSSD Board of Advisor Publication - (2013) - Alan Moghissi, Sorin R. Straja, and Betty Love, Peer Review and Scientific Assessment: A Handbook for Funding Organizations, Regulatory Agencies and Editors, Institute for Regulatory Science (2013)

Summary: This handbooks guides the reader through all of the important aspects of peer review and explains how they are applied in the design and operation of successful review and assessment programs.  Key topics include the selection of reviewers, identifying and mitigating conflicts of interest, and developing review criteria.  The more general question of how scientific claims can be evaluated and controversies resolved is also considered in an exploration of the Best Available Science concept.

ITSSD Board of Advisor Publication - (2009) - A. Alan Moghissi, Sorin R. Straja and Betty Love, Manual for Independent Peer Reviews and Independent Scientific Assessments, Institute for Regulatory Science (2009).   

Abstract - "The purpose of this manual is to describe the peer review processes developed by the Institute for Regulatory Science (RSI) in support of activities performed by government agencies at the federal, state, regional or local levels; various segments of industry; and other organizations.  It is based on a number of policies, statements, and traditions of various segments of the scientific community, including the engineering community.  Consistent with the historic tradition of science, the RSI peer-review and scientific assessment process are intended to provide an unbiased, independent, accurate, economical, and timely response to those organizations needing support on specific actions."

ITSSD Board of Advisor Publication - (2012) - A. Alan Moghissi, Dennis K. McBride, et al., Regulatory Sunshine: Application of Best Available Science Concept and Metrics for Evaluation of Science Claims to Regulatory Transparency, International Center for Regulatory Science, George Mason University and Potomac Institute for Policy Studies (2012) 

Summary: This article discusses why transparency of scientific information used by government is not only desirable but critical for the acceptability of policy decisions.  The 'Regulatory Science Sunshine Act' proposed for the Environmental Protection Agency (EPA) is equally applicable not only to other regulatory agencies but also fundamentally to all policy decisions.  It would require that regulatory agencies develop processes, procedures, and methods for each regulatory decision that is based on or includes science, such as: 1) Identification of assumption judgments, default data, other similar systems used in the regulatory process, identification potential alternatives, and how the conclusion would be different if alternative assumptions, judgments and similar parameters were used; 2) Description of the content of all mathematical formulations in words; 3) Ensuring that the scientific information used in regulatory decisions is written in a language that is understandable to a knowledgeable non specialist and the average person; 4) Demonstrating clear and unambiguous justification for the inclusion of societal objectives in their scientific assessment; and 5) Complying with relevant ethical requirements.  The proposed Regulatory Science Sunshine Act also would require that regulatory agencies make a concerted effort to develop relevant processes, procedures, and methods to respond to the needs identified above.

Nongovernmental

ITSSD Amicus Curiae Brief, filed with the United States Supreme Court in case Docket No. 12-1271, supporting the Chamber of Commerce of the United States of America, State of Alaska and American Farm Bureau Federation v. Environmental Protection Agency, one of twelve separately filed cases previously consolidated by the United States Court of Appeals for the District of Columbia Circuit with the case of Coalition for Responsible Regulation et al. v. Environmental Protection Agency, 684 F. 3d 115 (D.C. Cir. 2012).  These twelve cases challenged the validity of the climate science upon which the USEPA Administrator based its Final Greenhouse Gas ("GHG") Endangerment and Cause or Contribute Findings under Clean Air Act ("CAA") Section 202(a).  Such Findings triggered EPA's issuance of economically significant national mobile and stationary source GHG emissions control regulations. 

Issue: The ITSSD brief explained how EPA's peer review and administrative review of the mostly third-party-developed climate science-related assessments produced by other federal agencies and the United Nations Intergovernmental Panel on Climate Change ("IPCC"), upon which the EPA Administrator "primarily" and "heavily" relied in reaching positive CAA Section 202(a) Findings, had failed to adhere to the highest and most rigorous peer review, conflict-of-interest and transparency  standards applicable to highly influential scientific assessments ("HISAs") imposed by the Information Quality Act and OMB and EPA IQA-implementing guidelines.  

Congressional Hearing Testimonies of Members of ITSSD Board of Advisors (Nov. 30, 2011) -

The Hearing Charter identified the hearing's purpose as securing: external perspectives on the need to reauthorize and reform science, research and development activities at the Environmental Protection Agency ("EPA"); explore the intersection of agency-supported science and its regulatory mission; and focused recommendations to raise the level, quality, usefulness, and objectivity of EPA science, including any necessary changes to the Environmental Research, Development and Demonstration Authorization Act.  The House Science, Space and Technology Committee issued a press release summarizing the witnesses' findings entitled, EPA Science Processes in Need of Reform, Witnesses Say (Nov. 30, 2011).

Statement of A. Alan Moghissi, President, Institute for Regulatory Science - ​The Need for Regulatory Science Transparency at EPA,  

Written Testimony of Gary E. Marchant, J.D., M.P.P., Ph.D, Lincoln Professor of Emerging Technologies, Law & Ethics Faculty Director, Center for Law, Science & Innovation, Sandra Day O' Connor College of Law, Arizona State University, Tempe, AZ, at: Fostering Quality Science at EPA: Perspectives on Common Sense Reform, Hearing Before the Committee of Science, Space and Technology, Subcommittee on Energy and Environment, U.S. House of Representatives, 112th Cong. (Nov. 30, 2011).   

ITSSD Board of Advisor Interview - (2012) - A. Alan Moghissi Interview With Evergreen Magazine, The EPA Has a Political Agenda That Doesn't Have Much of Anything To Do With Science - A Conversation With Dr. Alan Moghissi, One of America's Finest and Most Outspoken Scientists (Evergreen Foundation Fall 2012) (pp. 5-13)

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