HLS Student Papers

Part I of this article introduces the American seafood and shellfish industry and provides some background data on the composition of the market as well as consumption patterns in the United States. Consideration is given not only to the domestic commercial supply, but also to a significant import segment of the market as well as recreational fishing and harvesting. Part II addresses the various risks to seafood and shellfish consumers. Again, though risks across the entire industry are addressed, particular attention is given to those risks specific to the shellfish industry. The risks discussed range from those inherent to different types of seafood to health hazards of purely human origin. Both the level of threat and the seriousness of these different health hazards are presented and analyzed. Current means of risk identification and reduction are examined briefly throughout this section. Part III begins a more specific examination of past attempts at health and safety regulation of the shellfish industry. This portion of the article provides the historical context of current shellfish safety programs while documenting the development and ultimate demise of previous attempts at industry regulation. The section begins with the creation of the National Shellfish Sanitation Program (NSSP) in 1925 and continues through its merger into the International Shellfish Sanitation Conference in 1998. Along the way, several safety issues are introduced that continue to present serious challenges to present efforts to regulate the seafood and shellfish industries. Part IV addresses the existing regulatory regime in the seafood and shellfish industries. While particular attention is given to the HACCP program instituted by the Food and Drug Administration, other existing programs such as that run by the National Marine Fisheries Service under the National Oceanic and Atmospheric Administration are also addressed. The current status and vitality of the National Shellfish Sanitation Program, now over 75 years old, is also considered. In Part V, recent criticisms of the existing regulatory regime are addressed. Inadequacies of the current system are discussed along with potential overlap and duplication among the various programs in existence. The primary focus of this portion of the article is directed toward the recent reports issued by the General Accounting Office in January and July 2001. The article concludes in Part VI with a prospective consideration of the safety issues facing the seafood and shellfish industry. The General Accounting Office recommendations are considered in light of the historical basis for the current system. Possible alternative approaches to providing for the safety of seafood and shellfish consumers are discussed, and finally, the article ends with a brief consideration of some recurring themes within health and safety regulation in the seafood and shellfish industries.

Boiler explosions plagued the steamboat industry during the early years of its existence (1816-1852), costing thousands of lives and prompting the federal government to enact private welfare regulation for the first time. Congress faced many challenges in this task, including opposition from steamboat owners, disagreement as to the causes of explosions and how best to prevent them, and, most seriously, concerns about its authority to interfere with private property rights and the extent of its constitutional power to regulate commerce. Despite these obstacles, Congress succeeded in enacting two groundbreaking pieces of legislation, one in 1838 and the other in 1852 that tackled the steamboat issue head-on. Together, they established the first federal agency responsible for the regulation of a private industry, in large part due to the public's outcry over the explosions and its demand for government intervention. The resulting dual safeguards of boiler specifications and an administrative system of inspection transformed the steaming industry and dramatically reduced the number of annual steamboat boiler explosions and resulting fatalities in the United States. More importantly, these acts and this new empowerment of the federal government set the precedent for its future role in consumer protection through the regulation of private industry, paving the way for federal agencies like the Food and Drug Administration that today are taken for granted as the guardians of public welfare.

This paper begins with a brief overview of the psychology of rumor and a discussion of the impact of Internet technology on the dissemination of rumors. Part II examines the three consumer rumors presented above as case studies illustrating the problem of Internet hoaxes and attempts by governmental and private actors to halt the circulation of false information about a product or company. Part III discusses whether the traditional enforcement tools used by the FDA and FTC are adequate and appropriate to address consumer rumors, as well as reviewing the options available to private companies adversely impacted by such a rumor.

What has emerged from recent media coverage, White House statements, and congressional hearings is a fairly clear picture of the threat to public health posed by "rogue" online pharmacies and the obstacles facing state and federal agencies in regulating them. Exactly who should be regulating online pharmacies and what, if any, additional legislation is necessary is less clear. Several different courses of actions have been proposed to address the almost universally perceived threats to public health and the privacy of consumer information. What is very clear is that nobody is certain how to address the fact that many of these "rogue" online pharmacies are based in foreign countries, and this is cause for serious concern. The following discussion provides an overview of how online pharmacies operate and what potential risks they pose to public health. It also outlines the laws and authorities that regulate online pharmacies, the obstacles to enforcing existing laws, and recent actions taken against "rogue" websites. Finally, it offers an overview of several different recent proposals designed to meet the challenges of online pharmacies.

This paper attempts to provide a chronological history of the significant events and influences that have shaped the regulation of biotechnology by the Federal Food and Drug Administration. This paper first chronicles the evolution of each of the separate fields of regulation into which biological products are categorized by the FDA (drugs, biologics, devices, and foods). Part III of this paper then discusses the first call for governmental regulation of biotechnology and the struggle for regulatory form that this shift in administrative authority created. Part IV describes the Coordinated Framework for the Regulation of Biotechnology. Part V discusses subsequent efforts, both Congressional and administrative, to reform the regulation of biotechnology by FDA.

The paper proceeds in three parts. Part II provides an overview of NEPA. The section examines the statutory text and foundational case law to understand how the statute operates and the obligations it imposes on agencies. The section also examines the legislative history of the statute to determine to what extent, if any, Congress directly addressed the issue of how food safety or human health could impact the environment. Part III examines the FDA and the statutes it administers, the Food, Drug, and Cosmetic Act (FDCA). The purpose of the section is to outline the scope of the agency's jurisdiction and highlight those areas of jurisdiction where decision making could affect the environment. In Part IV, the paper takes a largely historical approach to analyze how the FDA and NEPA have interacted. In six major episodes, or 'rounds,' the FDA has confronted its obligations under NEPA. There are two categories of episodes: those in which the FDA has taken steps, some more grudging than others, to comply with NEPA and those in which NEPA could have played a more extensive role in FDA decision making to identify or avoid environmental harm. Several of these six rounds have been independently addressed by academic literature. This paper does not attempt to replicate the scope or detail of those efforts. The principal intent of this paper is to compile all these episodes in one place -- to examine the FDA's interaction with NEPA holistically and to observe change in attitudes and strategies through time.

Over the past twenty years, physicians have carried out bone marrow transplants with increasing success. As the procedure gains in acceptance and availability over the coming years, our nation will be faced with important policy choices regarding the regulation of bone marrow transplantation.

In this paper, I will argue that national uniformity should be granted to all FDA-regulated products and should include preemption of both state labeling and safety standards as well as state product liability laws. Cosmetics and food should be treated the same as FDAMA treats OTC drugs. Although the FDA has developed different regulatory regimes for each product, the FDA has established the optimal standards for all of its products, and states should not interfere to preclude harmonization. Congress should also prevent state courts and lay juries from interfering with the goals of the FDA to both ensure the safety of products, while at the same time, encourage innovation. The Supreme Court has said, "state regulations can be as effectively exerted through an award of damages as through some form of preventive relief. The obligation to pay compensation can be, indeed is designed to be, a potent method of governing conduct and controlling policy." Congress needs to recognize that state tort claims impose requirements for safety and effectiveness that can be just as detrimental to the goals of national uniformity as state labeling and safety standards. The benefits of national uniformity for FDA-regulated products can never be fully realized if state tort suits interfere as an additional regulatory tool to monitor safety. FDAMA itself is inherently contradictory, because the explicit allowance of state tort suits conflicts with the Act's goal of national uniformity. Manufacturers are caught in a "physical impossibility," because even if manufacturers comply with nationally uniform FDA standards, the threat of tort liability results in an incentive to overwarn and to include information that departs from a uniform FDA standard.

By tracing the history of food labeling laws, we can see that labeling regulation has come a long way from the branding of bread during the reign of King John in the thirteenth century. The food label has gone from a mere enforcement devise to a marketing tool to an instrument for fulfillment of nutrition policy. Labeling regulation has transformed from simple rules to avoid fraud and mispresentation to complex affirmative requirements to help the consumer understand the labeled food in the context of their overall diet.

Since the 1930s the Food and Drug Administration ("FDA") has taken broad Jurisdiction over eveiyday products in an attempt to ensure public health. Despite that mission, the FDA In particular and the Federal government In general has done little to regulate the tobacco Industry. Recently, however, the Commissioner of the FDA, Dr. David A. Kessler. raised the possibility of regulating the cigarette industry. But is the simple regulation of cigarettes permitted by the Federal Food, Drug and Cosmetic Act of 1938, which grants the FDA jurisdiction over products? Given the unanimity of opinion on the hazards of cigarette smoking, the answer to this question is no, and yet the conclusion that cigarettes must be banned seems too radical to seriously imagine. As a result, the context in which the FDA has approached cigarette smoking should be analyzed.