Combining Environmental and Economic Performance for Bioprocess Optimization.

Biochemical production faces economic and environmental challenges that need to be overcome to enable a viable and sustainable bioeconomy. We propose an assessment framework that consistently combines environmental and economic indicators to support optimized biochemical production at early development stages. We define internally consistent system boundaries and a comprehensive set of quantitative indicators from life cycle assessment (LCA) and techno-economic assessment (TEA) to combine environmental and economic performance in a single score. Our framework enables the identification of trade-offs across environmental and economic aspects over the entire biochemical life cycle. This approach provides input for the optimization of future biochemicals in terms of overall sustainability, to overcome prevailing obstacles in the development of biochemical production processes.

Roundup litigation discovery documents: implications for public health and journal ethics.

This paper reviews the court-released discovery documents obtained from litigation against Monsanto over its herbicide Roundup and through Freedom of Information Act requests (requests to regulatory agencies and public universities in the United States). We sought evidence of corporate malfeasance and undisclosed conflicts of interest with respect to issues of scientific integrity. The findings include evidence of ghostwriting, interference in journal publication, and undue influence of a federal regulatory agency.

Ten years of REACH - An animal protection perspective.

It has now been 11 years since the EU's new chemicals legislation (Regulation No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals [REACH]) came into force. Two important statements in the REACH Regulation in relation to animal testing and alternatives are: Article 1(1), which states that one of its purposes is to promote alternative methods; and Article 25(1), which states that animal testing should be used as a last resort. This review looks at the mechanisms that were put in place within REACH to achieve these aims and asks, not only if they are being implemented properly, but also if they have been sufficient. Whilst the chemical industry has heavily used data-sharing and read-across, this review concludes that nevertheless over 2.2 million animals have already been used in new tests for REACH registrations. This equates to an annual average of 275,000 animals; 58,000 more per year than the best-case estimate made by the European Commission in 2004. The use of in vitro and (Q)SAR approaches as standalone replacements for animal tests has been relatively low. The levels of funding for research into alternative methods remain low, and there are concerns over the speed of formal adoption of those that have been validated. In addition, there have been issues with the recognition that testing as a last resort and the promotion of alternative methods applies to all parties, including the Commission, Member States and the agency responsible, the European Chemicals Agency. This review provides ten recommendations for better implementation of these two key aspirations, as well as lessons to be learned for future similar legislation.

Chemical Leasing business models and corporate social responsibility.

Chemical Leasing is a service-oriented business model that shifts the focus from increasing sales volume of chemicals towards a value-added approach. Recent pilot projects have shown the economic benefits of introducing Chemical Leasing business models in a broad range of sectors. A decade after its introduction, the promotion of Chemical Leasing is still predominantly done by the public sector and international organizations. We show in this paper that awareness-raising activities to disseminate information on this innovative business model mainly focus on the economic benefits. We argue that selling Chemical Leasing business models solely on the grounds of economic and ecological considerations falls short of branding it as a corporate social responsibility initiative, which, for this paper, is defined as a stakeholder-oriented concept that extends beyond the organization's boundaries and is driven by an ethical understanding of the organization's responsibility for the impact of its business activities. For the analysis of Chemical Leasing business models, we introduce two case studies from the water purification and metal degreasing fields, focusing on employees and local communities as two specific stakeholder groups of the company introducing Chemical Leasing. The paper seeks to demonstrate that Chemical Leasing business models can be branded as a corporate social responsibility initiative by outlining the vast potential of Chemical Leasing to improve occupational health and safety and to strengthen the ability of companies to protect the environment from the adverse effects of the chemicals they apply.

Conflicts of interest in approvals of additives to food determined to be generally recognized as safe: out of balance.

IMPORTANCE: Food and Drug Administration (FDA) guidance allows food manufacturers to determine whether additives to food are "generally recognized as safe" (GRAS). Manufacturers are not required to notify the FDA of a GRAS determination, although in some instances they notify the agency. The individuals that companies select to make these determinations may have financial conflicts of interest. OBJECTIVE: To determine the extent to which individuals selected by manufacturers to make GRAS determinations have conflicts of interest between their obligations to ensure that the use of the additive is safe and their financial relationships to the company. DESIGN Using conflict of interest criteria developed by a committee of the Institute of Medicine, we analyzed 451 GRAS notifications that were voluntarily submitted to the FDA between 1997 and 2012. MAIN OUTCOMES AND MEASURES: Number of GRAS notices submitted to the FDA; frequency of various types of relationships between decision maker and additive manufacturer; frequency of participation on GRAS panels by individuals; and number of GRAS safety determinations identified by the FDA that were not submitted to the agency. RESULTS: For the 451 GRAS notifications, 22.4% of the safety assessments were made by an employee of an additive manufacturer, 13.3% by an employee of a consulting firm selected by the manufacturer, and 64.3% by an expert panel selected by either a consulting firm or the manufacturer. A standing expert panel selected by a third party made none of these safety assessments. The 290 panels that made GRAS determinations had an average of 3.5 members, with a maximum of 7. Ten individuals served on 27 or more panels; 1 individual served on 128 panels (44.1%). At least 1 of the 10 individuals with the most frequent service was a member of 225 panels (77.6%). CONCLUSIONS AND RELEVANCE: Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS. The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.

Vinyl chloride industry in the courtroom and corporate influences on the scientific literature.

Pressure from the vinyl chloride (VC) industry on researchers involved in industry-sponsored studies and on regulatory agencies has been documented since 1970s. This commentary describes the influence of a lawsuit pursued by workers of an Italian VC plant on the recent scientific debate on VC exposure and risk of hepatocellular carcinoma (HCC). Original studies carried out by consultants of the public prosecutors and by independent researchers supported the above association. VC-industry consultants published two reviews during the lawsuit, claiming that liver angiosarcoma was the only VC-related cancer. The judges concluded that the evidence of the association between HCC and VC was still not convincing. After the trial, the risk of HCC was confirmed by a re-assessment of VC carcinogenicity from the International Agency for Research on Cancer, but other subsequent industry-funded reviews criticized the new evidence. Industry-funded authors cited each other, and rarely disclosed conflicts of interest. Based on a network of collaborating researchers, industrial interests can shape the literature enhancing the background noise surrounding the scientific evidence.

Moral disengagement in the corporate world.

We analyze mechanisms of moral disengagement used to eliminate moral consequences by industries whose products or production practices are harmful to human health. Moral disengagement removes the restraint of self-censure from harmful practices. Moral self-sanctions can be selectively disengaged from harmful activities by investing them with socially worthy purposes, sanitizing and exonerating them, displacing and diffusing responsibility, minimizing or disputing harmful consequences, making advantageous comparisons, and disparaging and blaming critics and victims. Internal industry documents and public statements related to the research activities of these industries were coded for modes of moral disengagement by the tobacco, lead, vinyl chloride (VC), and silicosis-producing industries. All but one of the modes of moral disengagement were used by each of these industries. We present possible safeguards designed to protect the integrity of research.

The politics of lead toxicology and the devastating consequences for children.

At virtually every step in the history of the uncovering of lead's toxic qualities, resistance was shown by a variety of industrial interests to the association of lead and toxicity. During the first half of the last century, three primary means were used to undermine the growing body of evidence: first, the lead industry sought to control lead research by sponsoring and funding university research. In the 1920s, the General Motors Company, with the aide of DuPont and Standard Oil Companies, established the Kettering Labs, a research unit at the University of Cincinnati which, for many decades was largely supported by industry funds. In the same decade, the lead industry sponsored the research of Joseph Aub at Harvard who worked on neurophysiology of lead. A second way was to shape our understanding of lead itself, portraying it as an indispensable and healthful element essential for all modern life. Lead was portrayed as safe for children to use, be around, and even touch. The third way that lead was exempted from the normal public health measures and regulatory apparatus that had largely controlled phosphorus poisoning, poor quality food and meats and other potential public health hazards was more insidious and involved directly influencing the scientific integrity of the clinical observations and research. Throughout the past century tremendous pressure by the lead industry itself was brought to bear to quiet, even intimidate, researchers and clinicians who reported on or identified lead as a hazard. This article will draw on our previous work and add new documentation of the trajectory of industry attempts to keep out of the public view the tremendous threat of lead poisoning to children.

The past suppression of industry knowledge of the toxicity of benzene to humans and potential bias in future benzene research.

Petrochemical industry representatives often withhold information and misinterpret positive evidence of toxicity of benzene, even from their own research, also discouraging or delaying disclosure of findings of adverse effects to the public. They now appear to be attempting to influence study results in industry's favor by offering predetermined conclusions about study results as part of an effort to draw financial support for the studies. The American Petroleum Institute is currently raising funds for benzene research being conducted in China for which it has already announced the intended conclusions.