Public health protection

State intervention in man s activities to protect the health of the inhabitants goes back to prehistory. The motivation may not have been altogether altruistic the king acted to protect his subjects because he regarded them as his property. Public health protection began for disease control. With industrialization, came the need for control of even more hazardous forces and substances. This extended protection became technological in accident analysis and response. Present efforts in controlling risk, such as from nuclear power, are a continuation of this development. 

The philosophy of public health protection used by the AEC and pursued ever since, is the use of multiple independent barriers, each a significant shield for the public. The last barrier involves the removal of people from the area over which the radioactive plume is expected to pass, interdiction of food supplies and the use of prophylaxis to reduce the iodine dose. Blood... 

Using the fourUi maximum rather than the third (as originally proposed by USEPA) will provide greater stability in Uie designaUon of areas, consistent w ith providing strong public health protections ... 

Even though usually less explicit, this practice is very common whether one considers bona fide, peer reviewed, scientific reports or official public health protection documents<39). The scientific literature is full of subtle practices of the genre. Tables, for instance, contain entries which are footnoted or otherwise marked to indicate significance based on the magic p<.05(40-44). ... 

Note that in these several examples certain kinds of assumption are used to estimate intakes. In the TCE examples all adults were assumed to consume 2 liters of water each day and were also assumed to weigh 80 kg. Obviously in any population exposed to the contaminated water, it is unlikely that these two assumptions apply with high accuracy to any actual individuals. In fact the assumptions may be quite inaccurate for some individuals, even while they might be reasonably representative, on average, for most. It is in fact not possible to conduct risk assessments without the use of assumptions such as these, and so the individuals that are the subjects of typical risk assessments might be described as generic rather than actual. As will become clear in the later chapters on risk assessment, this type of generic evaluation is appropriate and useful for the purposes of public health protection. 

While the sulfamates themselves probably have low HOP, they can hydrolyze at low rates to the more toxic carbamates under conditions of food storage, preparation, or digestion. From the work of Sullivan ( ), it appears that latent sulfamate toxicity can also be potentiated through enzymatic conversion in some shellfish to the corresponding decarbamoyl toxins. The value needed for public health protection is therefore the potential human oral potency, the HOP that product might attain under a worst-case scenario of conversions. 

Strong Public Health Protection Information on pharmaceutical development studies in new drug applications is generally limited and varies from application to application. This creates an uncertain environment and curtails FDA reviewers ability to make risk-based decisions and inhibits their ability to recognize and assess how quality was built in. Risk communication between review and inspection staff is also inhibited. Appropriate pharmaceutical development information can improve public health by improving FDA s risk-based decisions and by facilitating continuous improvement. 

In achieving this target, all countries should seek common, science-based, international standards. FSIS should continue to ensure that equivalent inspection systems and standards for meat and poultry products exist in all countries exporting such products to the United States, especially in light of the better US safety standards expected under Hazard Analysis Critical Control Points (HACCP). FDA also should evaluate the food safety systems of other countries, with the purpose of entering into agreements with those countries having food safety systems that offer equivalent levels of public health protection to those of the United States or that can provide assurance that their products will be in compliance with FDA requirements. 

The oral reference dose (Oral RfD) is an estimate of the daily exposure of a person to a contaminant that is likely to be without appreciable risk of a deleterious non-carcinogenic effect during a lifetime (USEPA http //www.epa.gov/iris/). Oral RfD values for POP concentrations in seafood types are presented in Table 16.5, together with the daily intake of POPs from seafood consumed in Singapore. Daily intakes of POPs from seafood are below the oral RfD. The cancer benchmark concentration (Dougherty et al., 2000) represents the exposure concentration at which a lifetime cancer risk equates to one excess cancer death in one million persons. This level is defined as the public health protective concentration in the Congressional House Report to the Food Quality Protection Act of 1996 in the USA. Cancer benchmark concentrations were exceeded for DDTs, heptachlor, and PCBs (See Table 16.5). The cancer hazard ratio is the ratio of the MDI for a specific contaminant relative to the cancer benchmark concentration. The cancer hazard ratio represents the extent to which average daily exposure exceeds the benchmark concentration. The cancer hazard ratio of seafood consumption... 

The FDA should accept, where legally permissible, the equivalent standards, compliance activities, and enforcement programs of other countries, provided that the FDA is satisfied that such standards, activities, and programs meet the FDA s level of public health protection. 

The regulatory framework governing biological medicinal products is based on the European Community Treaty, which aims at the free movement of goods within the European Union. Although the legal base is built on the principle of free trade of medicinal products within the European Union, the essential aim of any rules governing the production, distribution, and use of medicinal products must be firmly based on protection of public health. Recital 3 of Directive 2001/83/EC notes that the objective of public health protection must be attained by means that do not hinder the development of the pharmaceutical industry or trade in medicinal products within the European Union. 

Assessing risks—and, for drugs and medical devices, weighing risks against benefits—is at the core of FDA s public health protection duties. By ensuring that products and producers meet certain standards, FDA protects consumers and enables them to know what they are buying. For example, the... 

Necessity of Risk-Assessment Tools in Solid Waste Emissions in Analyzing Environment and Public Health Protection... 

Efficient project management of technical works at a landfill site for public health protection... 

Bultman M. W., Fisher F. S., and Pappagianis D. An overview of the ecology of soil-bome human pathogens. In Medical Geology—Earth Science in Support of Public Health Protection (ed. O. Selinus). Academic Press (in press). 

Selinus O. (ed.) Medical Geology—Earth Science in Support of Public Health Protection. Academic Press, London (in press). 

A historical sidebar about the California Low Emission Vehicle Program is appropriate here. The program dates back to 1986 when the California Air Resources Board (ARB) staff discussed and debated the fact that we could not achieve the 1987 Federal Clean Air Act public health protection target in spite of doing more than anyone anywhere to achieve clean air. In spite of the auto industry s assertions that they had already been driven to near-zero, more had to be done to reduce vehicle emissions. In fact, the ARB felt that California would never see clean air unless some percent of the vehicle population s emissions were, in effect, zero. But zero had to wait for the unveiling of GM s Impact electric vehicle prototype, the precursor to the EV-1, in 1990. This need, zero, is still true today. 

Of particular note (1) These first guidelines called for revising each risk assessment as better information became available, a goal that has been rarely realized. (2) Gaps in scientific knowledge were to be filled with public health protective assumptions to err on the side of safety, an early application of the precautionary principle. 

The safety assessment scheme described above appears to have provided adequate public health protection, and will no doubt continue in use for some time to come. There are, however, certain limitations in the scheme that should be acknowledged. 

Fenner-Crisp P, Adams J, Balbus J et al. (2005). Application of developmental neurotoxicity testing to public health protection. Neurotoxicol Teratol, 27, 371. 

EPA has testified that the Army s current disposal program fully complies with or surpasses EPA requirements for environmental and public health protection. The incinerator at the Army s Johnston Atoll facility is... 

Thus far has fully complied with or surpassed EPA requirements for environmental and public health protection. 

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