risks of environmental tobacco smoke have also been used to support international smoking bans.

The passing and implementation of smoking bans provides many lessons for EPA and for other regulators. First, it emphasizes the importance of scientists and policy makers scrutinizing the quality of individual studies as part of appropriately determining the overall weight of the evidence and the uncertainty in it. Second, it demonstrates the need to consider the sources of scientific criticisms and uncertainties that are raised and to separate valid scientific criticisms from invalid ones. Third, it emphasizes that when considering economic factors and other factors, such as public acceptance, uncertainty based on anecdotal concerns about potential financial consequences might not reflect the actual effects of a regulation. Fourth, it illustrates the heterogeneity in public values and how acceptance of health-protective policies can shift over time, leading to new societal norms.


Listeria monocytogenes is a bacterium that causes listeriosis, a potentially fatal bacterial infection that can result from eating food contaminated with the bacterium (FDA and FSIS, 2003a). Listeriosis primarily affects pregnant women, older adults, and persons with weakened immune systems (FDA and FISIS, 2003a). Infections during pregnancy can lead to premature delivery, infection of the newborn, or stillbirth. Death occurs in 20 percent of cases of listeriosis (Swaminathan and Gerner-Smidt, 2007); CDC estimates that L. monocytogenes causes nearly 1,600 illnesses each year in the United States, including more than 1,400 hospitalizations and 255 deaths (Scallan et al., 2011). FDA and FSIS collaborated, in consultation with the CDC, to conduct a risk assessment of L. monocytogenes. In this section, the committee discusses that risk assessment and the uncertainty analyses in it and also discusses how FDA has used the results of that risk assessment to refine its policies around the control of L. monocytogenes in different food products within its regulatory purview.

Regulatory Background

L. monocytogenes can contaminate food contact surfaces and also non-food contact surfaces, such as floors and drains in food-processing facilities. The growth of L. monocytogenes is more difficult to control than the growth of most other bacteria. Temperatures at or below 40°F control the growth of most bacteria, but L. monocytogenes survives on cold surfaces and can multiply slowly at 32°F; temperatures of 0°F are required to completely stop L. monocytogenes from multiplying (FDA and FSIS, 2003b).

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