Regulatory Process

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Agustin J. Ros - One of the best experts on this subject based on the ideXlab platform.

Cary Coglianese - One of the best experts on this subject based on the ideXlab platform.

  • e rulemaking information technology and the Regulatory Process
    Administrative Law Review, 2004
    Co-Authors: Cary Coglianese
    Abstract:

    Regulatory agencies such as the Department of Transportation, Environmental Protection Agency, and Internal Revenue Service face significant information demands in crafting the thousands of new regulations the federal government issues each year. Before adopting new regulations, Regulatory agencies must solicit and analyze comments from the public as well as complete scientific, engineering, and economic analyses. By harnessing the power of digital technologies, electronic rulemaking -- or e-rulemaking, for short – could potentially reduce the informational burdens associated with making regulations. Not only may e-rulemaking make the Regulatory Process more manageable for federal agencies, it may also expand and enhance the public’s involvement in this important policymaking arena. For these reasons, interest in e-rulemaking is growing in Washington, D.C. E-rulemaking formed part of the Clinton Administration’s National Performance Review and it remains a component of the Bush Administration’s overall management plan. In addition, the E-Government Act of 2002 calls for federal agencies to explore the use of new technologies in rulemaking proceedings. In order to channel interest in e-rulemaking toward effective and meaningful innovations in Regulatory practice, the Kennedy School of Government’s Regulatory Policy Program convened two major workshops, bringing together academic experts from computer sciences, law, and public management along with key public officials involved in managing federal regulation. This paper summarizes the discussions that took place at these workshops and develops an agenda for future research on information technology and the rulemaking Process. It highlights the institutional challenges associated with using information technology in the federal Regulatory Process and suggests that in some cases existing rulemaking practices may need to be reconfigured in order to take full advantage of technological developments. Ultimately, the effective deployment of information technology to assist with government rulemaking will depend on integrating knowledge from across the social sciences, law, and information sciences.

  • E-Rulemaking: Information Technology and the Regulatory Process
    SSRN Electronic Journal, 2004
    Co-Authors: Cary Coglianese
    Abstract:

    In order to channel interest in e-rulemaking toward effective and meaningful innovations in Regulatory practice, the Kennedy School of Government's Regulatory Policy Program convened two major workshops, bringing together academic experts from computer sciences, law, and public management along with key public officials involved in managing federal regulation. This paper summarizes the discussions that took place at these workshops and develops an agenda for future research on information technology and the rulemaking Process. It highlights the institutional challenges associated with using information technology in the federal Regulatory Process and suggests that in some cases existing rulemaking practices may need to be reconfigured in order to take full advantage of technological developments. Ultimately, the effective deployment of information technology to assist with government rulemaking will depend on integrating knowledge from across the social sciences, law, and information sciences.Posted paper, uploaded January 2010, is the published version of the working paper originally posted February 2004.

  • litigating within relationships disputes and disturbance in the Regulatory Process
    Law & Society Review, 1996
    Co-Authors: Cary Coglianese
    Abstract:

    This article reports data that contrast with an extended tradition of viewing litigation as incompatible with ongoing relationships. Within the Regulatory Process at the U. S. Environmental Protection Agency (EPA), nongovernmental actors having the most sustained relationships with EPA are the ones most likely to engage in litigation against the agency. Litigation within Regulatory relationships is not explained by existing theory, which treats litigation largely as a function of relationships. A disturbance theory of disputing, which focuses on how litigation interacts with existing relationships, provides a more robust account of litigation generally and of its compatibility with ongoing Regulatory relationships.

Michiel A Heldeweg - One of the best experts on this subject based on the ideXlab platform.

  • regulation i presume said the robot towards an iterative Regulatory Process for robot governance
    Computer Law & Security Review, 2018
    Co-Authors: Eduard Fosch Villaronga, Michiel A Heldeweg
    Abstract:

    Abstract This article envisions an iterative Regulatory Process for robot governance. In the article, we argue that what lacks in robot governance is actually a backstep mechanism that can coordinate and align robot and Regulatory developers. In order to solve that problem, we present a theoretical model that represents a step forward in the coordination and alignment of robot and Regulatory development. Our work builds on previous literature, and explores modes of alignment and iteration towards greater closeness in the nexus between research and development (R&D) and Regulatory appraisal and channeling of robotics’ development. To illustrate practical challenges and solutions, we explore different examples of (related) types of communication Processes between robot developers and Regulatory bodies. These examples help illuminate the lack of formalization of the policymaking Process, and the loss of time and resources that the waste of knowledge generated for future robot governance instruments implies. We argue that initiatives that fail to formalize the communication Process between different actors and that propose the mere creation of coordinating agencies risk being seriously ineffective. We propose an iterative Regulatory Process for robot governance, which combines the use of an ex ante robot impact assessment for legal/ethical appraisal, and evaluation settings as data generators, and an ex post legislative evaluation instrument that eases the revision, modification and update of the normative instrument. In all, the model breathes the concept of creating dynamic evidence-based policies that can serve as temporary benchmark for future and/or new uses or robot developments. Our contribution seeks to provide a thoughtful proposal that avoids the current mismatch between existing governmental approaches and what is needed for effective ethical/legal oversight, in the hope that this will inform the policy debate and set the scene for further research.

  • regulation i presume said the robot towards an iterative Regulatory Process for robot governance
    Social Science Research Network, 2018
    Co-Authors: Eduard Fosch Villaronga, Michiel A Heldeweg
    Abstract:

    This project envisions an iterative Regulatory Process for robot governance. A theoretical model represents a step forward in the coordination and alignment of robot and Regulatory development. Our work builds on previous literature, and explores modes of alignment and iteration towards greater closeness in the nexus between research and development (R&D) and Regulatory appraisal and channeling of robotics’ development. To illustrate practical challenges and solutions, we explore different examples of (related) types of communication Processes between robot developers and Regulatory bodies. These examples help illuminate the lack of formalization of the policy making Process, and the loss of time and resources that the waste of knowledge generated for future robot governance instruments implies. We argue that initiatives that fail to formalize the communication Process between different actors and that propose the mere creation of coordinating agencies risk being seriously ineffective. We propose an iterative Regulatory Process for robot governance, which combines the use of an ex ante robot impact assessment for legal/ethical appraisal, and evaluation settings as data generators, and an ex post legislative evaluation instrument that eases the revision, modification and update of the normative instrument. In all, the model breathes the concept of creating dynamic evidence-based policies that can serve as temporary benchmark for future and/or new uses or robot developments. Our contribution seeks to provide a thoughtful proposal that avoids the current mismatch between existing governmental approaches and what is needed for effective ethical/legal oversight, in the hope that this will inform the policy debate and set the scene for further research.

John H. Ross - One of the best experts on this subject based on the ideXlab platform.

  • RISK ASSESSMENTS IN THE PESTICIDE Regulatory Process
    The Annals of occupational hygiene, 1993
    Co-Authors: Robert I. Krieger, John H. Ross
    Abstract:

    The risk assessment Process offers regulators, registrants, public interest groups and users a means of weighing apparent health effects of pesticides and other chemicals, and measuring their safety for use. This report contains the method for developing relative measures of safety for acute toxicity and expressions of risk for chronic toxicity and assesses-human exposure under a variety of extreme scenarios. Since workplace exposures usually exceed environmental exposures by two or more orders of magnitude, occupational experience with pesticides is critical to the Regulatory Process. Default assumptions, the adoption of conventional numbers in the absence of empirical data, for factors such as dermal absorption, metabolism, clearance and worker protective measures that seem conservative may weaken the reliability of the risk characterization Process and may reduce the likelihood of recognizing significant risk. An exposure-based Regulatory policy should feature measurements of absorbed dose validated using biomonitoring and margins of safety and estimates of risk that reflect human experience. This paper lists basic characteristics of unit Processes of risk assessment and presents some strategies and pitfalls of the Process as practiced in California in recent years.

Condos, Nicholas J. - One of the best experts on this subject based on the ideXlab platform.

  • U.S. EPA reregistration eligibility decision (RED) for the rodenticide cluster: overview of the Regulatory Process, response of registrants and stakeholders, and implications for agricultural and urban rodent control
    eScholarship University of California, 2000
    Co-Authors: Silberhorn, Eric M., Hobson, James F., Miller, Gerald H., Condos, Nicholas J.
    Abstract:

    After several years of reviewing study data and conducting risk assessments, in September of 1998 the U.S. Environmental Protection Agency (U.S. EPA) issued for comment a Reregistration Eligibility Decision (RED) document for pesticide products in the Rodenticide Cluster. The RED document covered 243 rodenticide products containing the following active ingredients: brodifacoum, bromadiolone, bromethalin, chlorophacinone, diphacinone and its sodium salt, and pival and its sodium salt. The U.S. EPA’s human health risk assessment in the RED document concluded that it was concerned about the risk to children due to accidental exposures to these chemicals through use in and around residences. With regard to ecological effects, the Agency concluded that there is a high risk of secondary poisoning, especially to mammals, from the use of these rodenticides outdoors in rural and suburban areas. In order to address the potential risks to children, the U.S. EPA initially required several mitigation measures designed to minimize exposure (e.g., addition of dye and bittering agent to formulations, labeling changes). The Agency also initiated implementation of a Rodenticide Stakeholder Process through which these and other risk mitigation measures would be discussed and required as needed. To help mitigate potential risks to non-target wildlife, the Agency initially determined that all uses of field-bait rodenticides containing more than 0.005% of chlorophacinone or diphacinone were ineligible for reregistration. The U.S. EPA also decided that all rodenticide products labeled for field use (except those limited to manual underground baiting) should be reclassified as Restricted Use pesticides. This paper reviews the Regulatory Process for the Rodenticide Cluster RED and discusses the response of the California Department of Food and Agriculture (CDFA) and other registrants to the requirements proposed in the RED document including formation of the Rodenticide Registrants Task Force (RRTF). It also outlines how an on-going dialogue with the Agency, both through the Rodenticide Stakeholder Process and in separate discussions, has diminished the RED requirements from those originally proposed. In addition, the paper discusses the implications and potential impacts of the current RED reregistration requirements for those applicators involved in agricultural and urban rodent control