The U.S. Food and Drug Administration (FDA) announced recently that food products derived from some animal clones and their offspring are safe for human consumption. In response to criticism that it had failed to engage with ethical, social, and economic concerns raised by livestock cloning, the FDA argued that addressing normative issues prior to issuing a final ruling on animal cloning is not part of its mission. In this article, the authors reject the FDA's claim that its mission to protect (...) and advance public health can be accomplished without considering ethical issues or without making value judgments. The authors offer two arguments in support of their position. First, the agency's mission statement presupposes significant normative commitments and judgments. Second, the FDA's risk assessment of food products from cloned animals and their offspring is itself clearly shaped by a variety of normative commitments. (shrink)

The process of risk assessment of biotechnologies, such as genetically modified organisms (GMOs), has normative dimensions. However, the US’ Food and Drug Administration (FDA) seems committed to the idea that such evaluations are objective. This essay makes the case that the agency’s regulatory approach should be changed such that the public is involved in deciding any ethical or social questions that might arise during risk assessment of GMOs. It is argued that, in the US, neither aggregative nor deliberative (representative) democracy (...) ought to be used to make such determinations. Instead, participatory (deliberative) democracy should be the means by which members of the polity decide which normative concerns ought to underlie FDA’s assessment of GMOs. This paper uses a hypothetical case involving a new GM seed to make that argument. (shrink)

In the context of the mandated phaseout of methyl bromide, California’s strawberry industry has increased its use of chloropicrin, another soil fumigant that has long been on the market. However, due to its 2010 designation as a toxic air contaminant, the US Environmental Protection Agency and California’s Department of Pesticide Regulation have developed enhanced application protocols to mitigate exposures of the chemical to bystanders, nearby residents, and farmworkers. The central feature of these mitigation technologies are enhanced buffer zones between treated (...) fields and nearby buildings. Not only do buffer zones inherently privilege neighbors over farmworkers, but the determinations of the size of these buffer zones are also based on acceptable threshold levels and probabilities that allow significant exposures to those they are designed to protect. Moreover, these protocols require human monitors to detect sensory irritation. While the science and technology studies literature is highly useful for understanding the inextricability of science and politics in developing protective measures and is attentive to what counts as data in setting acceptable thresholds, it tends to overlook that social sorting is intrinsic to such regulation. We thus turn to Foucault’s biopolitics to make sense of regulations that are designed to protect but inherently allow some to become ill. Doing so illuminates how determinations of the bright line are at once technical–political as well as implicit decisions about whose bodies count. (shrink)