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The application of single-use systems, or disposables, has increased dramatically in the past 10 years. Although some elements of the pharmaceutical and biotech manufacturing process were single-use and therefore disposable and not reused, the majority of the process equipment and fluid path was cleaned and reused by end users. Today, much more of the manufacturing process is composed of single-use systems, and there are some biotech plants that use single-use systems exclusively. Because of this increasing reliance on suppliers, there is an urgent need for more formal standards specifically for single-use system technology. The objective of this PDA-sponsored workshop held on May 14, 2014 was twofold: (1) to promote a harmonized approach to supporting single-use system activities within the industry and in so doing to minimize duplication of efforts, and (2) to communicate ongoing single-use system initiatives among the group. Representatives of ASME, ASTM, BPOG, BPSA, ELSIE, PDA, PQRI, and USP, as well as representatives of CBER and CDER of FDA, attended. LAY ABSTRACT: Today, the majority of pharmaceutical and biotech drug manufacturing equipment is cleaned and reused. However, in the past 10 years, the use of disposable manufacturing systems has increased dramatically; there are even some biotech-derived drugs that are manufactured entirely using single-use technology. This movement toward disposables has placed increased reliance on disposable equipment suppliers, each of which manufactures its products independently to meet customer needs. This fact has led to non-uniformity in design for connectors and similar sub-processes, and has made the need for more formal industry standards. The objective of this PDA-sponsored workshop held on May 14, 2014 was twofold: (1) to promote a harmonized approach to supporting single-use system projects within the industry and in so doing to minimize duplication of efforts, and (2) to communicate ongoing single-use system initiatives among the group. Representatives of industry associations and standard-setting organizations, as well as representatives of the U.S. Food and Drug Administration, attended.

Uncertainty over the consequences of unprecedented global warming is central to environmental insecurity. Global warming threatens to exacerbate all other ecological stresses and menaces human populations and economies. Despite scientific efforts, great uncertainties still pervade crucial aspects of the climate change process and its consequences. Yet integrated assessment models widely used to analyze climate policy options, such as the Nordhaus DICE model, establish that model outputs are highly sensitive to plausible alternative parameter values. This paper further explores uncertainties by substituting probability distributions for pre-determined values of key parameters in the DICE model. It then draws randomly from these probability distributions to implement a Monte Carlo analysis of policy outcomes, generating hundreds of policy simulations. An important finding is that the sacrifice in world consumption entailed in keeping the rise in global temperatures below two degrees centigrade would likely be negligible if emitting countries cooperate in adopting efficient mitigation policies. In other words, the cost of insurance against dangerous climate change is close to zero. Thus, the result of this analysis suggests that science and economics agree on keeping climate change below a level threatening serious damage.

The best way to reduce greenhouse gas emissions on a sustained basis, says the author, is a cap-and-trade policy. Prices may fluctuate, but at least we get at the heart of the problem—steadily reducing emissions. A carbon tax will allow emissions to fluctuate as economic conditions cyclically turn from strong to weak and back again.

The weather varies, but climate change affects the frequencies with which particular weather occurs, including the frequencies of extreme weather, such as heavy storms, heat waves, and droughts. Mo...

Respiratory syncytial virus (RSV) is the leading cause of severe respiratory infection in children worldwide. Recombinant live attenuated viral preparations are one of the most promising strategies for vaccination but they typically possess poor thermostability. In this work, a library of compounds was screened and stabilizers were selected based on their ability to inhibit the aggregation of RSV perturbed at 56 degrees C. After screening and selection of excipients, the conformational stability of the RSV proteins was evaluated in the presence of potential stabilizers. The secondary and tertiary structures as well as aggregation/dissociation of RSV were monitored using circular dichroism and second derivative UV absorption spectroscopies and light scattering, respectively, as a function of temperature (10-90 degrees C). RSV membrane fluidity was also evaluated by generalized polarization of Laurdan fluorescence. Screening experiments showed that a variety of sugars, amino acids, polyols and polyanions inhibited the aggregation of viral particles. Conformational stability studies demonstrated that the addition of sugars and polyols stabilized RSV as indicated by a significant increase in the transition melting temperature (Tm) of both the secondary and tertiary structures as well as the gel to liquid crystalline membrane transition. These results should provide the basis for rational development of more physically stable formulations of live attenuated RSV vaccines.

The author shows by example that corporate lobbying on public policy issues is not always in the best interests of shareholders—or customers or employees. Best practice by leading companies provides oversight of lobbying by the board of directors, but far too few companies now employ such practices.

Financial markets are increasingly concerned about financial risks resulting from companies environmental exposures and are demanding greater disclosure and transparency. Despite long-established securities law and regulations requiring such disclosures, companies have not fully complied nor has the Securities and Exchange Commission vigorously pressed enforcement actions. Studies of disclosure of material environmental information in electricity generation and other environmentally-sensitive industries show a pattern of inadequate disclosure.

Quantitative analysis of 47 US investor-owned electric utilities’ environmental exposures to impending air quality and climate policies shows potentially material and highly differentiated financial impacts. For many companies the minimized compliance costs of a four-pollutant cap-and-trade regulatory regime would be less than those of a three-pollutant regime that omitted controls on carbon dioxide emissions. Fragmented regulatory requirements would have the highest compliance costs. The companies studied vary considerably in the adequacy of their financial reporting of these potential impacts. Greater transparency would benefit investors and the most favorably positioned companies.

It has been difficult to quantify the implications of environmental issues for a company9s performance. The authors demonstrate a novel approach to estimation of the costs of compliance with pending or possible environmental actions in the U.S. pulp and paper industry, noted for its energy use and emission of a wide range of toxic pollutants. They also question the adequacy of company disclosures related to financially material environmental risks.

This paper demonstrates a methodology for constructing asset accounts for a commercial fishery in which the stock, harvest, and effort level are out of sustainable equilibrium. The paper adopts the framework used by the U.S. Department of Commerce Bureau of Economic Analysis in its preliminary 1993 Integrated Economic and Environmental Accounts and follows methodologies recommended by the National Research Council committee constituted to review those efforts. The accounts were constructed for the period 1985 to 1995 for the Atlantic sea scallop fishery, a significant commercial fishery, using information obtained with the cooperation of the National Marine Fisheries Service from existing databases constructed for management purposes. No significant additional data collection was required for the purpose of this study. Differences between the net rent and user cost values of the stocks over this period indicate the inefficient exploitation of immature scallop populations.

The Atlantic sea scallop fishery in the USA and the offshore scallop fishery in the Canadian Maritimes offer a naturally occurring experiment in fisheries management. Canada has adopted a transferable output quota system and the USA has used a mix of size, effort and area controls. This paper compares the consequences over 15 years for the resource, the fishery, and the management regime.

This article demonstrates an approach for analyzing and communicating the financial implications of a company's environmental exposures. In environmentally sensitive industries, this approach can help companies to benchmark themselves against rivals, to identify major sources of environmental risk and opportunity, to assign financial values to risk-mitigating options, and to communicate their environmental strategies to the investment community and other stake-holders. © 2000 World Resources Institute. Used with permission.

The Clean Development Mechanism, defined in ArticleXII of the Kyoto Protocol to the UN Framework Convention on Climate Change, is a crucial instrument to enlist developing countries’ participation in emissions limitation, to reduce industrialized countries’ compliance costs, and to facilitate resource and technology transfers. However, the CDM contains perverse compliance incentives and is beset with problems of credit definition, monitoring, enforcement, and potentially high transactions costs. This paper defines some important design safeguards and suggests an alternative approach should the Kyoto Protocol eventually be renegotiated.

The literature on the use of environmental taxes inthe presence of distortionary (labor) taxes warns thata partial-equilibrium Pigouvian tax analysis is notappropriate because increasing the price of dirtygoods can futher aggravate the prexisting distortions. This argument is most frequently made assuming thatlabor is taxed to meet a fixed revenue requirement.When a dirty good is also taxed, others argue thatthis lowers workers' real wages, causing people toreduce their labor supply below its already suboptimallevel, aggravating labor market distortions. However,most papers ignore the effect that a cleanerenvironment can have on labor supply. That is, mostpast work has assumed that the quality of theenvironment is weakly separable in the utilityfunction. We argue that a cleaner environment canincrease labor supply, at least partially offsettingany incentive for workers to decrease their laborsupply. Further, we show explicitly how relaxing theseparability assumption affects the standardresults.

There is substantial experimental, epidemiological and other evidence that many pesticides in widespread use around the world are immunosuppressive. This poses a potentially serious health risk in populations highly exposed to infectious and parasitic diseases, subject to malnutrition, and inadequately serve by curative health programmes. An expanded programme of research is needed to investigate this potential risk and to design precautionary measures.

(1993). Pollution and Energy Taxes: Their Environmental and Economic Benefits. Challenge: Vol. 36, No. 4, pp. 9-14.

A country can cut down its forests, erode its soils, pollute its aquifers and hunt its wildlife and fisheries to extinction, but its measured income is not affected as these assets disappear. Impoverishment is taken for progress.

The risks of extreme weather events are typically being estimated, by federal agencies and others, with historical frequency data assumed to reflect future probabilities. These estimates may not yet have adequately factored in the effects of past and future climate change, despite strong evidence of a changing climate. They have relied on historical data stretching back as far as fifty or a hundred years that may be increasingly unrepresentative of future conditions. Government and private organizations that use these risk assessments in designing programs and projects with long expected lifetimes may therefore be investing too little to make existing and newly constructed infrastructure resistant to the effects of changing climate. New investments designed to these historical risk standards may suffer excess damages and poor returns. This paper illustrates the issue with an economic analysis of the risks of relatively intense hurricanes striking the New York City region.

Deforestation in the tropics is a consequence of poor management inappropriate agricultural and tax policies and inattention to significant social and economic problems. Governments have not placed a high enough value on tropical forests. There is a summary and identification of causes of deforestation with specific examples and possible remedial actions to strengthen forest management capability. The destruction of tropical forests has increased within 10 years to the status of a serious problem. The result is an increasing risk to natural systems and build up of carbon dioxide the loss of habitat for plant and animal species and a severe economic loss. Fuelwood is lost as well as other forest resources. Recent studies have found that nontimber forest product income may exceed the value of timber harvest and provide the livelihoods of local residents i.e. the wild rubber revenues in Acre State Brazil. There are other consequences on soil water quality and local climate. Management problems include wastage by burning of timber and by destroying immature or less desirable trees in the process of extracting valuable timber. Sustained productivity is not practiced. Governments also do not collect the full resource value of timber harvested. There are also low royalties and taxes. Timber profits are concentrated in the hands of concession holders mill owners and timber traders who use the investment as a tax shelter or act as middlemen i.e. businessmen ministers senators and senior politicians. Effective supervision is not always possible; log smuggling and tax evasion occur. Governments fail to invest enough in forest management i.e. Indonesian trained foresters must rely on concessionaires for transportation. Fees are based on the wood extracted not destroyed or damaged. Inappropriate incentives contribute to inefficient wood processing within the country and economic losses. Indirect policies of "transmigration" or subsidized rural credit programs have impacts. Industrialized countries have profited from these forest policies. Development assistance agencies both help and hinder. International cooperation has begun under the Tropical Forest Action Plan and the Montreal Protocol. Programs that link debt reduction to better forest management need to be expanded.

All economists are familiar with the case for Pigovian taxes. However, this policy paradigm has proven to be inadequate in concept and in practice. Therefore, it has rarely been implemented in actual tax measures (OECD, 1994). Conceptually, the Pigovian paradigm treats market failures arising from waste discharges into the environment as exceptional and occasional, but the laws of thermodynamics dictate that virtually all materials drawn into industrial processes will sooner or later be dissipated as wastes (Georgescu-Roegen, 1971). In fact, as this paper demonstrates, most of these materials are very quickly discharged as wastes into the air, into surface and underground water, or onto land. Thus, environmental externalities are ubiquitous and inevitable and occur at all stages of the life-cycle of “production” and “consumption”, as the Resources for the Future pointed out in a classic article 25 years ago (Ayres and Kneese, 1969) . Nonetheless, economists have not yet incorporated this fundamental fact into their models and analyses.