Mark Rossi

Health risks posed by use of Di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: a critical review.

BACKGROUND Polyvinyl chloride plastics (PVC), made flexible through the addition of di-2-ethylhexyl phthalate (DEHP), are used in the production of a wide array of medical devices. From the late 1960s, leaching of DEHP from PVC medical devices and ultimate tissue deposition have been documented. METHODS A critical review of DEHP exposure, metabolism, and toxicity data from human and animals studies was undertaken. A brief analysis of alternatives to DEHP-plasticized PVC for use in medical device manufacture was completed. RESULTS DEHP leaches in varying concentrations into solutions stored in PVC medical devices. Certain populations, including dialysis patients and hemophiliacs may have long-term exposures to clinically important doses of DEHP, while others, such as neonates and the developing fetus, may have exposures at critical points in development. In vivo and in vitro research links DEHP or its metabolites to a range of adverse effects in the liver, reproductive tract, kidneys, lungs, and heart. Developing animals are particularly susceptible to effects on the reproductive system. Some adverse effects in animal studies occur at levels of exposure experienced by patients in certain clinical settings. DEHP appears to pose a relatively low risk of hepatic cancer in humans. However, given lingering uncertainties about the relevance of the mechanism of action of carcinogenic effects in rodents for humans and interindividual variability, the possibility of DEHP-related carcinogenic responses in humans cannot be ruled out. CONCLUSIONS The observed toxicity of DEHP and availability of alternatives to many DEHP-containing PVC medical devices presents a compelling argument for moving assertively, but carefully, to the substitution of other materials for PVC in medical devices. The substitution of other materials for PVC would have an added worker and community health benefit of reducing population exposures to DEHP, reducing the creation of dioxin from PVC production and disposal, and reducing risks from vinyl chloride monomer exposure.

Chemical alternatives assessment: enabling substitution to safer chemicals.

As potentially or actually harmful ingredients are identified in commercial products, the goal is to replace them with safer alternatives. Yet a chemical ingredient is hardly a modular component that can be easily switched out. Further, replacement could remove one hazard and introduce others. To avoid this stymieing problem and ease an innovator’s choice of ingredients, Lavoie et al. report on a decision-making approach developed by the EPA’s Design for Environment program. A few case experiences illustrate its utility and recommend further use.

Leaders in sustainable development: how agents of change define the agenda

This article provides an overview of the Eighth Annual Greening of Industry Conference, Sustainability: Ways of Knowing/Ways of Acting. Held in Chapel Hill, NC (USA), 14–17 November 1999, the conference featured diverse visions of sustainability and a range of views on which societal actors should play leading roles in setting the sustainability agenda. The conference revealed a dichotomy between corporate and public visions of sustainability: who should define the agenda, who should lead the transition and the degree of change needed to achieve a sustainable society. Presenters at the conference highlighted innovative sustainability actions of corporations, the challenges and successes of collaborative approaches, and the shift in the NGO tactics towards the corporate role in defining the sustainability agenda. A challenge for future Network conferences is how to catalyse fruitful links and mergers among various visions of sustainable development and the leading agents of change. To that end, a research agenda is proposed. Copyright

The power of incrementalism: environmental regulation and technological change in pulp and paper bleaching in the US

This article explores environmental regulation as a driver of technological change through a case study ofthe US pulp and paper industry. It analyses two sets of variables that influence the pace and direction of environmentally oriented technological change: industry structure and regulatory design. As would be expecded from a mature productive unit, when confronted with environmental challenges, the US pull, and paper industry demonstrates a strong preference for incremental technological change. The case suggests that the traditional approaches to standard-setting in the US have not challenged this preference. For the pulp and paper industry, there is considerable uncertainty regarding the strategic advantages of alternative technologies, due to uncertainly in further environmental regulation and the relatively small difference in cost between incremental and radical innovations for may mills. This case suggests that an alternative approach for promoting the diffusion of environmental enhancing radical...

The Architecture of Chemical Alternatives Assessment

Chemical alternatives assessment is a method rapidly developing for use by businesses, governments, and nongovernment organizations seeking to substitute chemicals of concern in production processes and products. Chemical alternatives assessment is defined as a process for identifying, comparing, and selecting safer alternatives to chemicals of concern (including those in materials, processes, or technologies) on the basis of their hazards, performance, and economic viability. The process is intended to provide guidance for assuring that chemicals of concern are replaced with safer alternatives that are not likely to be later regretted. Conceptually, the assessment methods are developed from a set of three foundational pillars and five common principles. Based on a number of emerging alternatives assessment initiatives, in this commentary, we outline a chemical alternatives assessment blueprint structured around three broad steps: Scope, Assessment, and Selection and Implementation. Specific tasks and tools are identified for each of these three steps. While it is recognized that on-going practice will further refine and develop the method and tools, it is important that the structure of the assessment process remain flexible, adaptive, and focused on the substitution of chemicals of concern with safer alternatives.

Require Safer Substitutes and Solutions: Making the Substitution Principle the Cornerstone of Sustainable Chemical Policies

Currently, chemical regulations in the United States do not prioritize the production and use of inherently safe chemicals. At present, when regulations get passed to target a chemical for control, safer substitutes are not the goal nor are there specific guidelines or tools used to achieve Green Chemistry, Clean Production, or sustainable product design. In most cases, the replacement is often just as hazardous or simply a reduction of the quantity or concentration of the toxic substance that has been targeted. In contrast, by placing the Substitution Principle at the heart of new chemical policies and regulations, hazardous chemicals would be replaced with less hazardous alternatives or preferably alternatives for which no hazards can be identified. This would hasten the uptake of Green Chemistry, or environmentally benign chemical synthesis. Substituting hazardous chemicals goes beyond finding a drop-in chemical alternative and can include systems, materials or process changes. Regulatory drivers include a clear timeline for phase out of priority chemicals based on their inherent hazard, mandatory substitution planning for hazardous chemicals, financial and technical support for companies to find safer materials, and increased funding for green chemistry development and uptake by companies.

Advancing alternatives analysis: The role of predictive toxicology in selecting safer chemical products and processes

Alternatives analysis (AA) is a method used in regulation and product design to identify, assess, and evaluate the safety and viability of potential substitutes for hazardous chemicals. It requires toxicological data for the existing chemical and potential alternatives. Predictive toxicology uses in silico and in vitro approaches, computational models, and other tools to expedite toxicological data generation in a more cost-effective manner than traditional approaches. The present article briefly reviews the challenges associated with using predictive toxicology in regulatory AA, then presents 4 recommendations for its advancement. It recommends using case studies to advance the integration of predictive toxicology into AA, adopting a stepwise process to employing predictive toxicology in AA beginning with prioritization of chemicals of concern, leveraging existing resources to advance the integration of predictive toxicology into the practice of AA, and supporting transdisciplinary efforts. The further incorporation of predictive toxicology into AA would advance the ability of companies and regulators to select alternatives to harmful ingredients, and potentially increase the use of predictive toxicology in regulation more broadly. Integr Environ Assess Manag 2017;13:915-925.

BUSINESSES AND ADVOCACY GROUPS CREATE A ROAD MAP FOR SAFER CHEMICALS: THE BIZNGO PRINCIPLES FOR CHEMICALS POLICY

This paper details how businesses and environmental organizations are collaborating to define and implement a visionary agenda for integrating safer chemicals into products, describing the challenges they confront and how they are overcoming those challenges. The framework for this assessment is the Principles for Chemicals Policy developed by the Business-NGO Working Group for Safer Chemicals and Sustainable Materials (BizNGO). The four principles—1) knowing and disclosing chemicals in products, 2) assessing and avoiding hazards, 3) committing to continuous improvement, and 4) supporting public policies and industry standards—while appearing to be straightforward, are, in fact, very complex to implement in practice. Together businesses and environmental organizations are charting a path to safer chemicals by sharing best practices, addressing technical aspects of safer chemicals substitution, and analyzing and supporting public policies that advance the rapid development and diffusion of greener chemicals in the economy.