Overview of REACH: Issues Involved in the Registration of Metals.

New European legislation known as REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) was introduced in 2007 to increase the speed at which the health and/or environmental risks of industrial chemicals were being assessed and managed (REACH (EC) No 1907/2006). REACH consolidated earlier chemicals-control statutes and placed the burden of assessing, and identifying the means to manage risks on industry. This paper details the REACH process for controlling and managing hazardous chemicals and challenges encountered in applying the provisions of REACH and the guidance documents available from European Chemical Agency. Special attention is paid to challenges in evaluating potential health risks of metals such as aluminum and aluminum compounds. Lessons learned from over a decade of experience with REACH legislation are also noted.

The blood of my veins - mercury, Minamata and the soul of Japan.

The methylmercury contamination of Minamata Bay during the WWII postwar period resulted in thousands of Japanese citizens suffering horrific neurological injury. Fear and miscommunication destroyed and changed family and social structure. In addition, the Minamata poisoning caused momentous changes in the civic discourse in Japan and was an instrumental event in the democratization of the country. This manuscript describes the effects that the environmental contamination and human poising had in the transition of Japan from a feudal society to a democratic one.

Transparency of chemical risk assessment data under REACH.

The REACH regulation requires EU manufacturers and importers of substances to register information on the hazard and risk of their substances with the European Chemicals Agency (ECHA). Risk management of the substances is based on the provided information. It is known that conclusions on hazard and risk are influenced by expert judgements as well as potential conflict of interests. Thus, it is important that hazard and risk assessments are transparent and can be evaluated by a third party. The aim of this study is to scrutinize the transparency, i.e. the accessibility and comprehensibility, of information on substances registered under REACH. Data on repeated dose toxicity and hazard assessment conclusions were extracted for 60 substances from the REACH registration database available on the ECHA website. The data were compiled in a database for systematically evaluating the transparency of information related to the conclusions on hazard or risk. In addition, chemical safety reports (CSR) were requested from ECHA for five substances. The transparency of information on the hazard and risk of substances was found to be limited for several reasons. First, certain information was removed due to confidentiality and certain fields were not published because they could contain confidential information although the information had not been claimed confidential. Also, the extent to which registrants reported information varied, and the presentation of some data and certain terminology required further clarification. In addition, the data source for the majority of the key and supporting studies could not be identified due to confidentiality. Since registrants are only required to summarise studies, it cannot be verified whether all relevant information from non-public industry reports have been reported. Lastly, certain information related to the hazard and risk assessment were only reported in the CSR which is only available upon request; a time-consuming and work-intensive process. As information on registered chemicals is currently provided to the public, it is difficult to follow steps that are undertaken in the hazard and risk assessment. This limits the possibility for a third party to evaluate the assessment.

Improvements to enforcement of multilateral environmental agreements to control international shipments of chemicals and wastes.

Illegal trade in hazardous waste and harmful chemicals has caused severe damage on human health and the environment, and brought big challenges to countries to meet their commitments to related multilateral environmental agreements. Synergy-building, like organising law enforcement operations, is critical to address illegal trade in waste and chemicals, and further improve the effectiveness of environmental enforcement. This article discusses how and why law enforcement operations can help countries to implement chemical and waste-related multilateral environmental agreements in a more efficient and effective way. The research explores key barriers and factors for organising law enforcement operations, and recommends methods to improve law enforcement operations to address illegal trade in hazardous waste and harmful chemicals.

Advancing safer alternatives through functional substitution.

To achieve the ultimate goal of sustainable chemicals management policy­the transition to safer chemicals, materials, products, and processes­current chemicals management approaches could benefit from a broader perspective. Starting with considerations of function, rather than characterizing and managing risks associated with a particular chemical, may provide a different, solutions-oriented lens to reduce risk associated with the uses of chemicals. It may also offer an efficient means, complementing existing tools, to reorient chemicals management approaches from time-intensive risk assessment and risk management based on single chemicals to comparative evaluation of the best options to fulfill a specific function. This article describes a functional approach to chemicals management we call "functional substitution" that encourages decision-makers to look beyond chemical by chemical substitution to find a range of alternatives to meet product performance. We define functional substitution, outline a rationale for greater use of this concept when considering risks posed by uses of chemicals, and provide examples of how functional approaches have been applied toward the identification of alternatives. We also discuss next steps for implementing functional substitution in chemical assessment and policy development.

New technologies reduce greenhouse gas emissions from nitrogenous fertilizer in China.

Synthetic nitrogen (N) fertilizer has played a key role in enhancing food production and keeping half of the world's population adequately fed. However, decades of N fertilizer overuse in many parts of the world have contributed to soil, water, and air pollution; reducing excessive N losses and emissions is a central environmental challenge in the 21st century. China's participation is essential to global efforts in reducing N-related greenhouse gas (GHG) emissions because China is the largest producer and consumer of fertilizer N. To evaluate the impact of China's use of N fertilizer, we quantify the carbon footprint of China's N fertilizer production and consumption chain using life cycle analysis. For every ton of N fertilizer manufactured and used, 13.5 tons of CO2-equivalent (eq) (t CO2-eq) is emitted, compared with 9.7 t CO2-eq in Europe. Emissions in China tripled from 1980 [131 terrogram (Tg) of CO2-eq (Tg CO2-eq)] to 2010 (452 Tg CO2-eq). N fertilizer-related emissions constitute about 7% of GHG emissions from the entire Chinese economy and exceed soil carbon gain resulting from N fertilizer use by several-fold. We identified potential emission reductions by comparing prevailing technologies and management practices in China with more advanced options worldwide. Mitigation opportunities include improving methane recovery during coal mining, enhancing energy efficiency in fertilizer manufacture, and minimizing N overuse in field-level crop production. We find that use of advanced technologies could cut N fertilizer-related emissions by 20-63%, amounting to 102-357 Tg CO2-eq annually. Such reduction would decrease China's total GHG emissions by 2-6%, which is significant on a global scale.

A step change towards risk assessment in the 21st century.

Chemical Regulation and the means by which data is generated for the purposes of risk assessment is undergoing a tremendous shift. There is a strong impetus in Europe, in particular, to move towards non-animal approaches to address data gaps for specific endpoints either in lieu of testing or as part of weight of evidence approaches within integrated testing strategies (ITS). An Exposure assessment considering workers and/or consumers is a critical component of a robust risk assessment. The EU chemicals legislation REACH, for example, provides considerable flexibility in the application of non-testing approaches such as (Q)SARs, chemical categories and read-across for data gap filling. There have been a number of efforts aimed at developing technical guidance, tools, and techniques for non-testing and tiered exposure approaches. Despite these efforts, there remains limited practical insight about how these approaches can be applied in the assessment of substances. Here, we first provide a background of the available approaches and how they can and should be practically utilised to address REACH requirements.

Primary hepatocyte cultures as in vitro tools for toxicity testing: quo vadis?

Cultures of primary hepatocytes are versatile tools that can serve many in vitro toxicity testing purposes. However, they cope with dedifferentiation, a process that is already initiated during the hepatocyte isolation procedure and that is manifested as the progressive loss of functionality upon subsequent cultivation. A number of strategies to prevent dedifferentiation have been introduced over the last decades, all which aim at re-establishing the in vivo hepatocyte micro-environment in vitro, but that are of merely limited success. Recent mechanistic insight into the mechanisms that underlie hepatocyte dedifferentiation has opened new avenues for the development of novel approaches that target the actual causes of this deteriorative process and thus for the generation of a long-term hepatic in vitro tool. Such experimental system is urgently needed, especially in the light of the stringent European legislative modifications that are currently encountered by the pharmaceutical, chemical and, particularly, the cosmetic industry.

From (before) Bhopal to (after) BP: trade secrets and the right to know.

This paper discuses the tensions between, on the one hand, workers' and communities' right to know about occupational and environmental hazards, and on the other hand, trade secrets and the rights of their corporate owners. We first discuss the role of trade secrets in economic development in the context of the benefits claimed for free markets. We then describe the ongoing struggles of workers and communities in the United States for access to information about hazards. The third section of the paper is a discussion of the reformulation of labor and occupational health and safety regulation as matters of human rights, again focusing on the situation in the United States. The final section is a discussion of the implications of the human rights approach for the occupational and environmental health practitioner. Although the paper focuses primarily on the U.S. experience, we believe that the lessons learned may be broadly applicable.