Open Access. Powered by Scholars. Published by Universities.®
- Keyword
-
- Administrative law (3)
- FDA (3)
- Regulation (3)
- Social media (3)
- Commercial speech (2)
-
- Publicity (2)
- Administrative (1)
- Administrative Law (1)
- Agency (1)
- Agency enforcement (1)
- CC&R (1)
- CCRs (1)
- CFPB (1)
- Cfpb (1)
- Cigarettes (1)
- Common-interest community (1)
- Cost-Benefit Analysis (1)
- Data (1)
- Data Policy (1)
- Databases (1)
- Device (1)
- Electricity Imports (1)
- Energy Law (1)
- Energy Trade (1)
- Energy law (1)
- Environmental law (1)
- FTC (1)
- Fda (1)
- Fed (1)
- Federal Administrative Rulemaking – Role of Cost-Benefit Analysis (1)
Articles 1 - 18 of 18
Full-Text Articles in Law
Information Mischief Under The Trump Administration, Nathan Cortez
Information Mischief Under The Trump Administration, Nathan Cortez
Faculty Journal Articles and Book Chapters
The Trump administration has used government information in more cynical ways than its predecessors. For example, it has removed certain information from the public domain, scrubbed certain terminology from government web sites, censored scientists, manipulated public data, and used “transparency” initiatives as a pretext for anti-regulatory policies, particularly environmental policy. This article attempts to tease out an emerging “information policy” for the Trump administration, explain how it departs from the information policies of predecessors, and evaluate the extent to which both legal and non-legal mechanisms might constrain executive discretion.
Digital Health And Regulatory Experimentation At The Fda, Nathan Cortez
Digital Health And Regulatory Experimentation At The Fda, Nathan Cortez
Faculty Journal Articles and Book Chapters
For well over a decade the U.S. Food and Drug Administration (FDA) has been told that its framework for regulating traditional medical devices is not modern or flexible enough to address increasingly novel digital health technologies. Very recently, however, the FDA introduced a series of digital health initiatives that represent important experiments in medical product regulation, departing from longstanding precedents applied to therapeutic products like drugs and devices. The FDA will experiment with shifting its scrutiny from the pre-market to the post-market phase, shifting the locus of regulation from products to firms, and shifting from centralized government review to decentralized …
Regulation By Database, Nathan Cortez
Regulation By Database, Nathan Cortez
Faculty Journal Articles and Book Chapters
The federal government currently publishes 195,245 searchable databases online, a number of which include information about private parties that is negative or unflattering in some way. Federal agencies increasingly publish adverse data not just to inform the public or promote transparency, but to pursue regulatory ends ⎯ to change the underlying behavior being reported. Such "regulation by database" has become a preferred method of regulation in recent years, despite scant attention from policymakers, courts, or scholars on its appropriate uses and safeguards.
This Article, then, evaluates the aspirations and burdens of regulation by database. Based on case studies of six …
Policymaking By Proposal: How Agencies Are Transforming Industry Investment Long Before Rules Can Be Tested In Court, James W. Coleman
Policymaking By Proposal: How Agencies Are Transforming Industry Investment Long Before Rules Can Be Tested In Court, James W. Coleman
Faculty Journal Articles and Book Chapters
The conventional wisdom is that an executive agency’s scope of action and power depends on how easy it is to reverse agency decisions in court. If non-deferential judges provide industry with prompt review of agency decisions, the agency’s power is limited. And if courts are unlikely to second-guess the agency’s interpretations, then private actors have little choice but to comply. But in recent years, agencies have begun to rely on a new weapon in this struggle with courts and industry — the power of proposed rules to achieve regulatory outcomes. When regulations will affect long-term capital investments, companies must set …
Agency Publicity In The Internet Era, Nathan Cortez
Agency Publicity In The Internet Era, Nathan Cortez
Faculty Journal Articles and Book Chapters
This Report, prepared for the Administrative Conference of the United States (ACUS), details how federal agencies use modern forms of publicity - including press releases, agency web sites, searchable online databases, and social media - to achieve regulatory ends. It evaluates the benefits and burdens of modern agency publicity practices, using three agencies as case studies: the Food and Drug Administration (FDA); the Federal Trade Commission (FTC); and the Consumer Financial Protection Bureau (CFPB). Part V recommends a series of largely procedural reforms that balance the need for public disclosure with the need to protect those potentially injured by adverse …
Flowback: Federal Regulation Of Wastewater From Hydraulic Fracturing, Jeffrey M. Gaba
Flowback: Federal Regulation Of Wastewater From Hydraulic Fracturing, Jeffrey M. Gaba
Faculty Journal Articles and Book Chapters
Natural gas produced through hydraulic fracturing remains a critical, and controversial, component of U.S. energy production. A key environmental issue associated with fracking is the management and disposal of the enormous quantities of wastewater generated in the process.
Substantial federal authority exists to regulate fracking wastewater under the Resource Conservation and Recovery Act and the Clean Water Act. Regulation under RCRA, however, depends on classification of the wastewater as a RCRA “hazardous waste.” Although EPA has generally exempted oil and gas wastes, including fracking wastewater, from classification as a RCRA hazardous waste, it appears that fracking wastewater would not generally …
Importing Energy, Exporting Regulation, James W. Coleman
Importing Energy, Exporting Regulation, James W. Coleman
Faculty Journal Articles and Book Chapters
This Article identifies and addresses a growing contradiction at the heart of United States energy policy. States are the traditional energy regulators and energy policy innovators — a role that has only grown more important without a settled federal climate policy. But federal regulators and market pressures are increasingly demanding integrated national and international energy markets. Deregulation, the rise of renewable energy, the shale revolution, and new sources of motor fuel precursors like crude and ethanol have all increased interstate energy trade.
The Article shows how integrated national energy markets are driving states to regulate imported fuel and electricity based …
Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez
Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez
Faculty Journal Articles and Book Chapters
When Congress passed the nation’s first comprehensive tobacco bill in 2009, it replaced the familiar Surgeon General’s warnings, last updated in 1984, with nine blunter warnings. The law also directed the U.S. Food and Drug Administration ('FDA') to require color graphics to accompany the textual warnings. By law, the warnings would cover the top fifty percent of the front and back of tobacco packaging and the top twenty percent of print advertisements, bringing the United States closer to many peer countries that now require graphic warnings. Tobacco companies challenged the requirement on First Amendment grounds, arguing that the compelled disclosures …
The Mobile Health Revolution?, Nathan Cortez
The Mobile Health Revolution?, Nathan Cortez
Faculty Journal Articles and Book Chapters
Rarely does a class of technologies excite physicians, patients, financeers, gadgeteers, and policymakers alike. But mobile health — the use of mobile devices like smartphones and tablets for health or medical purposes — has captured our collective imagination. Observers predict that mobile health, also referred to as “mHealth” or “medical apps,” can save millions of lives, billions in spending, and democratize access to health care. Proponents argue that mobile health technologies will transform the ways in which we deliver, consume, measure, and pay for care; disrupting our sclerotic health care system.
This Article evaluates mobile health and its many ambitions. …
Promising To Be Prudent: A Private Law Approach To Mortgage Loan Regulation In Common-Interest Communities, Julia Patterson Forrester Rogers, Jerome Organ
Promising To Be Prudent: A Private Law Approach To Mortgage Loan Regulation In Common-Interest Communities, Julia Patterson Forrester Rogers, Jerome Organ
Faculty Journal Articles and Book Chapters
This Article explores one possible private law prescription that may help common-interest communities avoid the financial disaster associated with foreclosure epidemics-a financing restriction that would limit (1) the ability of any homeowner in a common-interest community to borrow excessively against the value of her home, and (2) the ability of lenders to make loans that a homeowner does not have the ability to repay. Part I of this Article begins in the Great Depression with a discussion of Neponsit Property Owners' Association v. Emigrant Industrial Savings Bank, w exploring how the case both fostered the development of common-interest communities and …
Adverse Publicity By Administrative Agencies In The Internet Era, Nathan Cortez
Adverse Publicity By Administrative Agencies In The Internet Era, Nathan Cortez
Faculty Journal Articles and Book Chapters
Nearly forty years ago, Ernest Gellhorn documented the potentially devastating impact that can occur when federal agencies issue adverse publicity about private parties. Based on his article, the Administrative Conference of the United States (ACUS) recommended that courts, Congress, and agencies hold agencies to clear standards for issuing such publicity. In the decades since, some agencies have adopted standards, but most have not. And neither the courts nor Congress has intervened to impose standards. Today, agencies continue to use countless forms of publicity to pressure alleged regulatory violators and to amplify their overall enforcement powers — all without affording due …
Generally Illegal: Npdes General Permits Under The Clean Water Act, Jeffrey M. Gaba
Generally Illegal: Npdes General Permits Under The Clean Water Act, Jeffrey M. Gaba
Faculty Journal Articles and Book Chapters
Under the Clean Water Act, it is unlawful for a point source to discharge pollutants without a National Pollutant Discharge Elimination System (“NPDES”) permit. Most NPDES permits are issued to individual facilities, but since 1979, EPA and States have had a process of issuing “General Permits” to satisfy the requirements of the Clean Water Act. These General Permits may contain enforceable effluent limitations and other requirements, but, unlike individual permit, they may apply to large numbers of sources discharging into many different bodies of water. The conditions of a General Permit are developed through a “notice and comment” process similar …
The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn
The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn
Faculty Journal Articles and Book Chapters
The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.
Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …
Valuation In Cost-Benefit Analysis: Choosing Between Offer Prices And Asking Prices As The Appropriate Measure Of Willingness To Pay, Gregory S. Crespi
Valuation In Cost-Benefit Analysis: Choosing Between Offer Prices And Asking Prices As The Appropriate Measure Of Willingness To Pay, Gregory S. Crespi
Faculty Journal Articles and Book Chapters
Cost-benefit analysis is a well-known technique for evaluating the merits of a policy by attempting to quantify in financial terms all of the costs and benefits that will result from its implementation. In this article, the author focuses on the important question of whether offer prices or asking prices are the theoretically appropriate measure in determining "willingness to pay" and overall efficiency consequences when conducting a cost-benefit analysis. The author surveys the existing literature on this valuation question and offers personal conclusions and recommendations.
New Sources, New Growth And The Clean Water Act, Jeffrey M. Gaba
New Sources, New Growth And The Clean Water Act, Jeffrey M. Gaba
Faculty Journal Articles and Book Chapters
This Article is discusses the means by which the federal Clean Water Act addresses the problem of growth in connection with the achievement and maintenance of water quality standards. The article discusses those existing water quality standards requirements that most directly affect the issue of growth. These include two distinct, and largely unrelated, sets of requirements. First, the Article discusses those provisions that affect the regulation of new or expanded discharges on waters not yet meeting water quality goals. These include, among others, the provisions of the TMDL process that address the allocation of waste loads to account for growth, …
Regulation By Bootstrap: Contingent Management Of Hazardous Wastes Under The Resource Conservation And Recovery Act, Jeffrey M. Gaba
Regulation By Bootstrap: Contingent Management Of Hazardous Wastes Under The Resource Conservation And Recovery Act, Jeffrey M. Gaba
Faculty Journal Articles and Book Chapters
In the last few years, EPA has increasingly employed the questionable technique of “contingent management” to regulate wastes under the federal Resource Conservation and Recovery Act (RCRA) in order to limit the costs and avoid the stigma of hazardous waste classification. Through the technique of contingent management, EPA has exempted materials from classification as hazardous waste on the condition that the materials are managed in the particular manner specified in the regulation. The ultimate bootstrap, contingent management allows EPA to regulate non-hazardous wastes over which it has no statutory jurisdiction. Perhaps more troubling, contingent management allows EPA to avoid the …
Regulation Of Municipal Solid Waste Through Taxation: The New York Recycling Incentive Tax, Jeffrey M. Gaba
Regulation Of Municipal Solid Waste Through Taxation: The New York Recycling Incentive Tax, Jeffrey M. Gaba
Faculty Journal Articles and Book Chapters
No abstract provided.
Mergers In Regulated Industries: The Role Of The Regulatory Agency, C. Paul Rogers Iii.
Mergers In Regulated Industries: The Role Of The Regulatory Agency, C. Paul Rogers Iii.
Faculty Journal Articles and Book Chapters
No abstract provided.