The Hallmarks of a Good Test: A Proposal for Applying the Functional Equivalent Rule From County of Maui v. Hawaii Wildlife Fund

The Clean Water Act generally requires a federal permit for the discharge of pollutants “from any point source” to navigable waters. It is undisputed that permits are required for discharges of pollutants from point sources that proceed “directly” to regulated waters. But there is much disagreement over the extent to which indirect point-source discharges are regulated. In an attempt to clarify, the United States Supreme Court in County of Maui v. Hawaii Wildlife Fund ruled that permits are required not just for direct point-source discharges, but also for any point-source discharge that is the “functional equivalent” of a direct point-source discharge. Unfortunately, the Court did not define the term “functional equivalent,” other than to offer a non-exhaustive list of seven factors to consider (emphasizing time and distance), and to admonish lower courts to both respect the states’ traditional authority over water pollution and be mindful of avoiding decisions that would encourage evasion of the Act’s permitting requirements. To pick up where County of Maui left off, this Article proposes the “hallmark” interpretation of the functional equivalent test. According to this approach, a pollutant discharge is the “functional equivalent” of a direct discharge (and therefore requires a permit) if it bears the hallmarks of a direct discharge—in other words, if the discharged pollutants still betray the traces of having been emitted from a “discernible, confined and discrete conveyance” (the statutory definition of “point source”). In contrast, if the pollutants lack those hallmarks, and thus are indistinguishable from pollutants added by nonpoint sources, then their discharge is not a regulated “functional equivalent.” This “hallmark” approach is consistent not only with County of Maui’s articulation of the functional equivalent rule, but also with the Court’s expectation of how that rule should be implemented. In support of the proposed hallmark analysis, the Article defines the reference point (“direct discharge”) and its functions, then explains how to determine whether the hallmarks of the pollutants at issue are equivalent to the hallmarks of a direct discharge. Finally, it cautions that, consistent with County of Maui’s admonition, the functional equivalent analysis must include a “perspective” check to prevent the Act from being used to undercut the states’ traditional authority over water quality, while also respecting Congress’ intent that certain point-source discharges be federally regulated

Poor quality vital anti-malarials in Africa - an urgent neglected public health priority

BACKGROUND: Plasmodium falciparum malaria remains a major public health problem. A vital component of malaria control rests on the availability of good quality artemisinin-derivative based combination therapy (ACT) at the correct dose. However, there are increasing reports of poor quality anti-malarials in Africa. METHODS: Seven collections of artemisinin derivative monotherapies, ACT and halofantrine anti-malarials of suspicious quality were collected in 2002/10 in eleven African countries and in Asia en route to Africa. Packaging, chemical composition (high performance liquid chromatography, direct ionization mass spectrometry, X-ray diffractometry, stable isotope analysis) and botanical investigations were performed. RESULTS: Counterfeit artesunate containing chloroquine, counterfeit dihydroartemisinin (DHA) containing paracetamol (acetaminophen), counterfeit DHA-piperaquine containing sildenafil, counterfeit artemether-lumefantrine containing pyrimethamine, counterfeit halofantrine containing artemisinin, and substandard/counterfeit or degraded artesunate and artesunate+amodiaquine in eight countries are described. Pollen analysis was consistent with manufacture of counterfeits in eastern Asia. These data do not allow estimation of the frequency of poor quality anti-malarials in Africa. CONCLUSIONS: Criminals are producing diverse harmful anti-malarial counterfeits with important public health consequences. The presence of artesunate monotherapy, substandard and/or degraded and counterfeit medicines containing sub-therapeutic amounts of unexpected anti-malarials will engender drug resistance. With the threatening spread of artemisinin resistance to Africa, much greater investment is required to ensure the quality of ACTs and removal of artemisinin monotherapies. The International Health Regulations may need to be invoked to counter these serious public health problems

Privatisation

The increased intelligence support required for the global war on terrorism has led to exponential growth in the private intelligence industry. The privatisation of intelligence has been particularly apparent in the USA, where public-private collaboration now permeates practically all parts of the national intelligence effort. This chapter seeks to understand what is the privatisation of intelligence, and why the USA has increasingly relied on the private sector to carry out core intelligence functions. An examination of the US case reveals the risks posed by the privatisation of intelligence and the need for governments to plan and control their reliance on the private sector