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.

Industrial chemical accidents: a growing health hazard in the Islamic Republic of Iran.

BACKGROUND: Occupational chemical accidents have increased in recent years in the Islamic Republic of Iran. In June and August 2015, three large explosions occurred at chemical warehouses in Rey, Tehran Province, and toxic vapours were released. AIMS: This study reviewed the three chemical accidents and assessed the extent to which the requirements for chemical safety and preparedness for chemical incidents under the International Health Regulations (IHR) are in place, and implemented at local and national levels in the Islamic Republic of Iran. METHODS: Data were obtained from secondary data and field visits to selected chemical plants. The secondary data were used to complete a 33-item checklist based on the IHR and the Ministry of Health and Medical Education checklist. A sample of 15 warehouses in Kahrizak district, Rey County, were visited to assess their capacity in relation to the IHR using a 15-item checklist. RESULTS: Some weaknesses were seen in the IHR capacity in the study area. The main weaknesses were lack of an effective surveillance system for chemical accidents and low levels of safety in chemical plants and warehouses. Other weaknesses included the lack of awareness of residents about chemical hazards and poorly equipped health centres for the management of victims of chemical accidents. The study area was not prepared for chemical accidents both within industrial plants and residential areas. CONCLUSIONS: Action is needed to improve the areas of weakness so as to achieve the necessary capacities for chemical safety, and preparedness and response to chemical incidents in line with the IHR.

Impact of REACH legislation on the production and importation of CMR (carcinogen, mutagen and reproductive) and explosive chemicals in Italy from 2011 to 2015.

On 1 June 2007, the European Commission issued the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) to protect both the environment and human health. We analyzed the impact of REACH in the Italian market considering the presence of chemicals, their diversity, importation and production during the period 2011-2015, with particular attention to products with toxic or explosive properties. There was a reduction of the chemicals on the market, in terms of tons but also the absolute numbers of types of compounds. The production reduction was particularly noticeable for explosive chemicals: -14.7%. CMR products did not show any statistically significant reduction in term of tons: -2.3%.

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.

How Canada Changed from Exporting Asbestos to Banning Asbestos: The Challenges That Had to Be Overcome.

Less than ten years ago, the asbestos industry enjoyed the support of every Quebec and Canadian political party. The Chrysotile Institute and the International Chrysotile Association, both located in Quebec, aggressively marketed asbestos around the world, claiming scientific evidence showed that chrysotile asbestos could be safely used. The industry created a climate of intimidation. Consequently, no groups advocating for victims of asbestos or campaigning for its outright ban existed in Quebec to challenge the industry. A campaign was launched to mobilize the scientific community to speak out. Working with scientists, activists, and asbestos victims around the world, a small group of Quebec scientists exposed the false arguments of the asbestos industry. They publicly and repeatedly challenged the unscientific and unethical asbestos policy of the government. By appealing to Quebec values and holding those in power accountable, the campaign won public support and succeeded against all odds in defeating the asbestos industry.

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.

History of EPI Suite™ and future perspectives on chemical property estimation in US Toxic Substances Control Act new chemical risk assessments.

Chemical property estimation is a key component in many industrial, academic, and regulatory activities, including in the risk assessment associated with the approximately 1000 new chemical pre-manufacture notices the United States Environmental Protection Agency (US EPA) receives annually. The US EPA evaluates fate, exposure and toxicity under the 1976 Toxic Substances Control Act (amended by the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act), which does not require test data with new chemical applications. Though the submission of data is not required, the US EPA has, over the past 40 years, occasionally received chemical-specific data with pre-manufacture notices. The US EPA has been actively using this and publicly available data to develop and refine predictive computerized models, most of which are housed in EPI Suite™, to estimate chemical properties used in the risk assessment of new chemicals. The US EPA develops and uses models based on (quantitative) structure-activity relationships ([Q]SARs) to estimate critical parameters. As in any evolving field, (Q)SARs have experienced successes, suffered failures, and responded to emerging trends. Correlations of a chemical structure with its properties or biological activity were first demonstrated in the late 19th century and today have been encapsulated in a myriad of quantitative and qualitative SARs. The development and proliferation of the personal computer in the late 20th century gave rise to a quickly increasing number of property estimation models, and continually improved computing power and connectivity among researchers via the internet are enabling the development of increasingly complex models.

How Canada's Asbestos Industry Was Defeated in Quebec.

Less than a decade ago, the Quebec asbestos industry enjoyed support from all the political parties in the Canadian House of Commons and the Quebec National Assembly, as well as from business and union organizations. Two lobby organizations (Chrysotile Institute and International Chrysotile Association) had significant global impact in promoting asbestos use and defeating asbestos ban efforts in developing countries. Quebec's two asbestos mines planned to expand operations and make Quebec the second biggest global asbestos exporter. With the aid of lobbyists, public relations consultants, and government financing, the asbestos industry came close to succeeding. The article examines how a campaign of international solidarity, involving scientific experts, asbestos victims, and health activists in Quebec, Canada, and overseas, succeeded in closing the two mines and defeating the political and social power that the Quebec asbestos industry had wielded for a century. This victory ended Canada's destructive role as global propagandist for the asbestos industry.

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.

Legal liability for Agent Orange-related illnesses: a reassessment of the 2005 VAVA case and prospects for new litigation.

Attempts through the US courts to hold the corporations responsible for the production of dioxin-contaminated herbicides used by the US military in the 1960s and early 1970s liable for their ongoing health consequences have failed. This article scrutinizes the most recent judgement - that of the United States District Court for the Eastern District of New York handed down in 2005 following a lawsuit brought by the Vietnam Association of Victims of Agent Orange/dioxin (VAVA). It is argued that despite this judgement there is the potential to bring a further legal case, with some prospect of success, on the basis of: (i) debatable legal judgements in the 2005 decision; (ii) new scientific evidence on the health effects of exposure to Agent Orange; and (iii) cases brought in other jurisdictions. The article concludes by noting the underfunding of ongoing remediation efforts, especially for the provision of assistance to affected individuals, and argues that it is desirable to oblige the producers of the herbicides to contribute financially to these efforts.