scholarly journals Regulations Matter: Epistemic Monopoly, Domination, Patents, and the Public Interest

Author(s):  
Zahra Meghani

AbstractThis paper argues that regulatory agencies have a responsibility to further the public interest when they determine the conditions under which new technological products may be commercialized. As a case study, this paper analyzes the US 9th Circuit Court’s ruling on the efforts of the US Environmental Protection Agency (EPA) to regulate an herbicide meant for use with seed that are genetically modified to be tolerant of the chemical. Using that case, it is argued that when regulatory agencies evaluate new technological products, they have an obligation to draw on data, analyses, and evaluations from a variety of credible epistemic sources, and not rely solely or even primarily on the technology developer. Otherwise, they create conditions for their own domination and that of the polity by the technology developer. Moreover, in the interest of advancing the public interest, regulatory agencies must evaluate new technologies in a substantively and procedurally unbiased manner.

Author(s):  
Kate Li ◽  
Karin Ricker ◽  
Feng C. Tsai ◽  
ChingYi J. Hsieh ◽  
Gwendolyn Osborne ◽  
...  

Many nitrosamines are potent carcinogens, with more than 30 listed under California’s Proposition 65. Recently, nitrosamine contamination of commonly used drugs for treatment of hypertension, heartburn, and type 2 diabetes has prompted numerous Food and Drug Administration (FDA) recalls in the US. These contaminants include the carcinogens NDMA (N-nitrosodimethylamine) and NDEA (N-nitrosodiethylamine) and the animal tumorigen NMBA (N-nitroso-N-methyl-4-aminobutyric acid). NMBA and NDEA are metabolically and/or structurally related to NDMA, an N-nitrosomethyl-n-alkylamine (NMA), and 12 other carcinogenic NMAs. These nitrosamines exhibit common genotoxic and tumorigenic activities, with shared target tumor sites amongst chemicals and within a given laboratory animal species. We use the drug valsartan as a case study to estimate the additional cancer risks associated with NDMA and NDEA contamination, based on nitrosamine levels reported by the US FDA, cancer potencies developed by California’s Proposition 65 program and the US Environmental Protection Agency (EPA), and specific exposure scenarios. These estimates suggest that nitrosamine contamination in drugs that are used long-term can increase cancer risks and pose a serious concern to public health.


Author(s):  
Jeffery Morris

Governments rely on regulatory science to support decisions related to the protection of human health and the environment. Not only is regulatory science produced and used differently than discovery-driven science practiced outside the government, but it also has its own means of being communicated within democratic societies and has its own challenges for public engagement. This chapter examines how regulatory science is communicated within the US federal government, principally by the US Environmental Protection Agency, using nanotechnology and biotechnology as case studies to illustrate the challenges of, and opportunities for, engaging the public on the use of scientific information to inform decisions on the introduction and use of emerging technologies into society.


1997 ◽  
Vol 1997 (1) ◽  
pp. 593-594
Author(s):  
Chris Christenson ◽  
Helen Bart

ABSTRACT The Canada-United States Joint Inland Pollution Contingency Plan was signed on July 25, 1994, by the minister of the Department of the Environment for Canada and the administrator of the United States Environmental Protection Agency. As stated in the letter of promulgation, the document provides for cooperative measures for dealing with accidental and unauthorized releases of pollutants that may cause damage to the environment and that may constitute a threat to the public health, property, or welfare along the shared inland boundary of the two nations. The plan divided the international boundary into five regional planning areas and mandated regional annexes that define the jurisdiction, roles, and response procedures of the regulatory and support agencies within each planning area. In our work on this project it is being made clear again and again that responders on both sides of our countries’ land border do not want to have their efforts hampered by what in an emergency could be arbitrary borders. We are committed to ensuring that the regulatory agencies in both countries are truly supportive of the on-scene responders, and that these annexes will only serve to enhance this support.


2009 ◽  
Vol 28 (4) ◽  
pp. 259-265 ◽  
Author(s):  
Joseph Zayed ◽  
Suzanne Philippe

Cadmium telluride (CdTe) thin film photovoltaic has become one of the leading technologies in the solar renewable energy market. Little is known about CdTe’s toxicological profile and regulatory agencies usually apply cadmium (Cd) criteria as a best approximation. However, CdTe may have different toxicological properties. The goal of this study is to determine the median lethal concentration/dose of CdTe and to compare these values with those of Cd. Using a rat model, the method followed conforms to that described in the Organisation for Economic Co-operation and Development (OECD) guidelines and in the US Environmental Protection Agency (EPA) Health Effects Test Guidelines. The median lethal concentration of CdTe was established at 2.71 mg/L, showing a very low variability between genders. The median lethal dose was determined to be greater than 2000 mg/kg. These results clearly show that CdTe is less toxic than Cd.


Public Voices ◽  
2016 ◽  
Vol 13 (2) ◽  
pp. 143
Author(s):  
Ken Nichols

Star Trek began as a 1960s television series led by a swashbuckling starship Captain, an intellectual off-world first officer, and a multicultural, heart-of-gold crew. In the third of a century since its appearance on our home screens, the series Gene Roddenberry created has become a world-wide phenomenon.Star Trek is also a rich treasure trove of administrative literature: The setting — usually a starship, sometimes a planetary government organization. The characters are clearly delineated, colorful, share common goals, distinguish between their personal and professional roles and concerns, and serve well as archetypes for distinct organizational personalities. And the missions are clear, benevolent, in the public interest, and frequently controversial.As you watch an episode of one of the four Star Trek series, how many of these facets can you observe?That’s public administration, all right, but in a very different wrapper


Author(s):  
Joy Damousi

It is in the US that the case study genre is reinvented within a politicised psychiatric-psychoanalytical framework in the work of Viola Bernard. Bernard’s writings pose enduring questions about the relationship between activism and US psychiatry, politics and race relations. This chapter traces Bernard’s efforts to develop a new, authoritative and politically effective narrative through her case notes and advocacy about black subjects. This involved mobilising the case study genre in the public domain at large, for political as well as medical purposes, in the context of a turbulent period in US history.


2011 ◽  
pp. 54 ◽  
Author(s):  
Garry Smith ◽  
Dan Rubenstein

While much has been written about the need for governments and the gambling industry to act responsibly in their provision of gambling, only modest advances have been made to establish best practices in this area. Worldwide, few governments even approach what William Eadington, in Trends in gambling and responsible gaming in the US and elsewhere (2003, http://www.888betsoff.com/links/04_presentations/Eadington.pdf), calls a stage-four level of responsible gambling stewardship, that is, the unconditional acceptance of strong measures to attenuate gambling-related harms. One of the cornerstones of a gambling regime oriented toward consumer safety and public interest is a commitment by government and the gambling industry to meet commendable standards for accountability and social responsibility. After studying the government's legislative framework for the operation and regulation of gambling in the province of Ontario (Canada), reviewing the province's gambling-related mission and public-policy statements, and interviewing key actors in the government's gambling administration, a template was developed for an optimally socially responsible and accountable gambling regime that operates in the public interest. The template, along with suggestions for improving accountability and social responsibility in the provision of gambling, is presented.


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