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Revitalizing the Information Quality Act as a Procedural Cure for Unsound Regulatory Science

Revitalizing the Information Quality Act as a Procedural Cure for Unsound Regulatory Science PDF Author: Lawrence A. Kogan
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

Book Description
This working paper explains in detail how the Information Quality Act and implementing guidelines from the Office of Management and Budget provide a procedural law mechanism to ensure the objectivity, quality, utility, integrity and reproducibility of highly influential scientific assessments developed by federal agencies and third parties, which agencies in turn “disseminate” as support for major agency regulations. OMB's guidelines, which are binding on all federal agencies, inter alia impose rigorous, uniform, peer-review process standards that govern agency peer-reviewer selection and retention practices. The guidelines also govern agencies' public disclosure obligations with respect to the data, computational and computer program inputs, assumptions, and applications that are incorporated into the assessments. In addition, OMB's guidelines require federal agencies to provide adequate administrative review mechanisms to ensure that affected persons can seek correction of agency-disseminated HISAs that agencies failed to adequately validate. Given the highly technical and specialized nature and characteristics of HISAs and the data on which they are based, the IQA and OMB's IQA guidelines anticipate that specialized review procedures separate and apart from ordinary APA notice-and-comment procedures, must be utilized under certain circumstances. The Environmental Protection Agency (“EPA”)'s 2009 Clean Air Act Section 202(a) Greenhouse Gas (“GHG”) Endangerment Findings and the decision-making process that led to the Findings, offer an ideal case study in how the IQA applies in the rulemaking context and how agencies can contravene the law. EPA's review of climate-science assessments disseminated in support of the Endangerment Findings were subject to four distinct IQA legal obligations, none of which EPA satisfied. These obligations related to: EPA-developed and peer-reviewed HISAs; third-party-developed and peer-reviewed HISAs; EPA's peer review of the Technical Support Document accompanying the Endangerment Findings that summarized and synthesized the numerous HISAs supporting them into a new HISA; and EPA's improper treatment of IQA stakeholder requests for correction. EPA and the National Oceanic and Atmospheric Administration (“NOAA”) failed to ensure that the peer reviews of the HISAs satisfied the IQA's most rigorous peer-reviewer independence, conflict-of-interest, and panel-balance standards. As the working paper explains, businesses and other stakeholders unsuccessfully sought correction of the faulty peer review processes employed to validate the scientific assessments supporting the Endangerment Findings, and reconsideration of the Findings themselves. Such final agency action potentially gives rise to legal challenges of EPA's failure to comply with the IQA's peer-review standards and its denial of specialized review of technical correction requests outside of the routine rulemaking process. A review of similar past legal actions filed by aggrieved regulatory stakeholders reflects that federal courts have been generally skeptical of IQA “private rights of action.” Those complaints foundered on plaintiffs' standing to sue, as well as their assertion of a “positive” right to properly peer-reviewed government information. This working paper proposes an alternative approach to judicial enforcement of the IQA, one which addresses past lawsuits' shortcomings. It explains this alternative approach in the context of a challenge to EPA's and NOAA's noncompliance with the IQA in its actions leading up to EPA's GHG Endangerment Findings. The suit would seek to enjoin EPA's use of all EPA, NOAA, and other agency-developed, improperly peer reviewed HISAs supporting the Findings, as well as the regulations they have spawned, until those HISAs have been peer reviewed once again in conformance with such IQA standards.

Revitalizing the Information Quality Act as a Procedural Cure for Unsound Regulatory Science

Revitalizing the Information Quality Act as a Procedural Cure for Unsound Regulatory Science PDF Author: Lawrence A. Kogan
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

Book Description
This working paper explains in detail how the Information Quality Act and implementing guidelines from the Office of Management and Budget provide a procedural law mechanism to ensure the objectivity, quality, utility, integrity and reproducibility of highly influential scientific assessments developed by federal agencies and third parties, which agencies in turn “disseminate” as support for major agency regulations. OMB's guidelines, which are binding on all federal agencies, inter alia impose rigorous, uniform, peer-review process standards that govern agency peer-reviewer selection and retention practices. The guidelines also govern agencies' public disclosure obligations with respect to the data, computational and computer program inputs, assumptions, and applications that are incorporated into the assessments. In addition, OMB's guidelines require federal agencies to provide adequate administrative review mechanisms to ensure that affected persons can seek correction of agency-disseminated HISAs that agencies failed to adequately validate. Given the highly technical and specialized nature and characteristics of HISAs and the data on which they are based, the IQA and OMB's IQA guidelines anticipate that specialized review procedures separate and apart from ordinary APA notice-and-comment procedures, must be utilized under certain circumstances. The Environmental Protection Agency (“EPA”)'s 2009 Clean Air Act Section 202(a) Greenhouse Gas (“GHG”) Endangerment Findings and the decision-making process that led to the Findings, offer an ideal case study in how the IQA applies in the rulemaking context and how agencies can contravene the law. EPA's review of climate-science assessments disseminated in support of the Endangerment Findings were subject to four distinct IQA legal obligations, none of which EPA satisfied. These obligations related to: EPA-developed and peer-reviewed HISAs; third-party-developed and peer-reviewed HISAs; EPA's peer review of the Technical Support Document accompanying the Endangerment Findings that summarized and synthesized the numerous HISAs supporting them into a new HISA; and EPA's improper treatment of IQA stakeholder requests for correction. EPA and the National Oceanic and Atmospheric Administration (“NOAA”) failed to ensure that the peer reviews of the HISAs satisfied the IQA's most rigorous peer-reviewer independence, conflict-of-interest, and panel-balance standards. As the working paper explains, businesses and other stakeholders unsuccessfully sought correction of the faulty peer review processes employed to validate the scientific assessments supporting the Endangerment Findings, and reconsideration of the Findings themselves. Such final agency action potentially gives rise to legal challenges of EPA's failure to comply with the IQA's peer-review standards and its denial of specialized review of technical correction requests outside of the routine rulemaking process. A review of similar past legal actions filed by aggrieved regulatory stakeholders reflects that federal courts have been generally skeptical of IQA “private rights of action.” Those complaints foundered on plaintiffs' standing to sue, as well as their assertion of a “positive” right to properly peer-reviewed government information. This working paper proposes an alternative approach to judicial enforcement of the IQA, one which addresses past lawsuits' shortcomings. It explains this alternative approach in the context of a challenge to EPA's and NOAA's noncompliance with the IQA in its actions leading up to EPA's GHG Endangerment Findings. The suit would seek to enjoin EPA's use of all EPA, NOAA, and other agency-developed, improperly peer reviewed HISAs supporting the Findings, as well as the regulations they have spawned, until those HISAs have been peer reviewed once again in conformance with such IQA standards.

Kentucky Journal of Equine, Agriculture, and Natural Resources Law

Kentucky Journal of Equine, Agriculture, and Natural Resources Law PDF Author:
Publisher:
ISBN:
Category : Agricultural laws and legislation
Languages : en
Pages : 164

Book Description


Civil Practice and Remedies Code

Civil Practice and Remedies Code PDF Author: Texas
Publisher:
ISBN:
Category : Civil procedure
Languages : en
Pages :

Book Description


Rigor Mortis

Rigor Mortis PDF Author: Richard Harris
Publisher: Hachette UK
ISBN: 046509791X
Category : Medical
Languages : en
Pages : 288

Book Description
An essential book to understanding whether the new miracle cure is good science or simply too good to be true American taxpayers spend $30 billion annually funding biomedical research, but over half of these studies can't be replicated due to poor experimental design, improper methods, and sloppy statistics. Bad science doesn't just hold back medical progress, it can sign the equivalent of a death sentence for terminal patients. In Rigor Mortis, Richard Harris explores these urgent issues with vivid anecdotes, personal stories, and interviews with the top biomedical researchers. We need to fix our dysfunctional biomedical system -- before it's too late.

Fostering Integrity in Research

Fostering Integrity in Research PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309391253
Category : Science
Languages : en
Pages : 327

Book Description
The integrity of knowledge that emerges from research is based on individual and collective adherence to core values of objectivity, honesty, openness, fairness, accountability, and stewardship. Integrity in science means that the organizations in which research is conducted encourage those involved to exemplify these values in every step of the research process. Understanding the dynamics that support â€" or distort â€" practices that uphold the integrity of research by all participants ensures that the research enterprise advances knowledge. The 1992 report Responsible Science: Ensuring the Integrity of the Research Process evaluated issues related to scientific responsibility and the conduct of research. It provided a valuable service in describing and analyzing a very complicated set of issues, and has served as a crucial basis for thinking about research integrity for more than two decades. However, as experience has accumulated with various forms of research misconduct, detrimental research practices, and other forms of misconduct, as subsequent empirical research has revealed more about the nature of scientific misconduct, and because technological and social changes have altered the environment in which science is conducted, it is clear that the framework established more than two decades ago needs to be updated. Responsible Science served as a valuable benchmark to set the context for this most recent analysis and to help guide the committee's thought process. Fostering Integrity in Research identifies best practices in research and recommends practical options for discouraging and addressing research misconduct and detrimental research practices.

Riegle Community Development and Regulatory Improvement Act of 1994

Riegle Community Development and Regulatory Improvement Act of 1994 PDF Author: United States
Publisher:
ISBN:
Category : Community development
Languages : en
Pages : 136

Book Description


Democracy and Education

Democracy and Education PDF Author: John Dewey
Publisher: Createspace Independent Publishing Platform
ISBN:
Category : Juvenile Nonfiction
Languages : en
Pages : 456

Book Description
. Renewal of Life by Transmission. The most notable distinction between living and inanimate things is that the former maintain themselves by renewal. A stone when struck resists. If its resistance is greater than the force of the blow struck, it remains outwardly unchanged. Otherwise, it is shattered into smaller bits. Never does the stone attempt to react in such a way that it may maintain itself against the blow, much less so as to render the blow a contributing factor to its own continued action. While the living thing may easily be crushed by superior force, it none the less tries to turn the energies which act upon it into means of its own further existence. If it cannot do so, it does not just split into smaller pieces (at least in the higher forms of life), but loses its identity as a living thing. As long as it endures, it struggles to use surrounding energies in its own behalf. It uses light, air, moisture, and the material of soil. To say that it uses them is to say that it turns them into means of its own conservation. As long as it is growing, the energy it expends in thus turning the environment to account is more than compensated for by the return it gets: it grows. Understanding the word "control" in this sense, it may be said that a living being is one that subjugates and controls for its own continued activity the energies that would otherwise use it up. Life is a self-renewing process through action upon the environment.

Revitalizing the Jamaican Economy

Revitalizing the Jamaican Economy PDF Author: Inter-American Development Bank
Publisher: IDB
ISBN: 193100384X
Category : Jamaica
Languages : en
Pages : 309

Book Description


The Federal Reserve System Purposes and Functions

The Federal Reserve System Purposes and Functions PDF Author: Board of Governors of the Federal Reserve System
Publisher:
ISBN: 9780894991967
Category : Banks and Banking
Languages : en
Pages : 0

Book Description
Provides an in-depth overview of the Federal Reserve System, including information about monetary policy and the economy, the Federal Reserve in the international sphere, supervision and regulation, consumer and community affairs and services offered by Reserve Banks. Contains several appendixes, including a brief explanation of Federal Reserve regulations, a glossary of terms, and a list of additional publications.

Food and Drug Administration Advisory Committees

Food and Drug Administration Advisory Committees PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309048370
Category : Medical
Languages : en
Pages : 239

Book Description
Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.