Tnational Alert on Swine Flu Syringes

ASIA PACIFIC

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~tNational alert on swine flu syringes

~w2009-10-15

Health authorities have issued a nationwide safety alert over the syringes issued under the federal government's swine flu vaccination program, after a health worker who suffers from a latex allergy had a severe reaction to the injection.Western Australia has asked GPs and others offering the vaccine to stop using the Chinese-made syringes, which are distributed by the federal Health Department, and is now trying to fill orders from 200 GPs for 40,000 latex-free versions. Other states have issued urgent alerts to doctors and nurses, asking them to first quiz patients on whether they are allergic to latex -- and to use a different syringe if they are. Allergy experts have described the alerts as "incredibly cautious", saying latex sensitivity is less common than it was 15 years ago, and it was very unlikely enough rubber could disperse into the injection solution to cause a problem. The 26-year-old Perth woman who suffered the anaphylactic reaction has fully recovered since the incident on Monday, and it remains unclear if latex caused her symptoms. However, the episode has triggered another flurry of concerns over elements of the roll-out of the swine flu vaccine, which has already been attacked on operational grounds. The Chinese syringes that triggered the issue conform to Australian regulatory standards. But because latex is not normally found in Australian syringes, health authorities say many doctors do not ask about latex allergy before vaccinating their patients. Connie Katelaris, professor of immunology and allergy at the University of Western Sydney, said the latex bungs were coated in silicone, and health officials had been "incredibly cautious" in issuing the alerts. While latex allergy used to be more common among healthcare workers, who are frequently exposed to latex, allergy rates even in this group were now thought to be only slightly higher than the general population rate of about 1 per cent. An even smaller number would have symptoms severe enough to cause a problem from a vaccination, she said. "It's very, very unlikely that any measurable level of latex would be found in any liquid in contact with it," Professor Katelaris said. A federal Health Department spokeswoman rejected criticisms of the vaccination program, saying the syringes met Australian standards and were registered by the Therapeutic Goods Administration. The reaction "is not related to the vaccine, and is extremely rare", she said.

The Australian, 9 October 2009

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~tProposed revisions to the workplace chemicals regulatory framework

~w2009-10-15

In July 2009 Safe Work Australia Council agreed to use the Draft National Standard for the Control of Workplace Hazardous Chemicals as the policy basis for new model OHS regulations for workplace chemicals. Now, Safe Work Australia have announced that they will commence drafting of model regulations for workplace chemicals based on the National Standard for the Control of Workplace Hazardous Chemicals – referred to as the ‘policy proposal’. The introduction of the new draft Australian Criteria for the Classification of Hazardous Chemicals (the Classification Criteria) is to introduce to the Australian workplace the international classification criteria for classifying and labelling hazardous chemicals as contained in the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). This draft Classification Criteria supports the Policy Proposal (the basis of model regulations covering the safe management of both dangerous goods and hazardous substances used in the workplace) and is scheduled to be introduced into the Australian workplace in 2012 at the time model legislation is put in place. The draft Classification Criteria is a large and complex document based on the 3rd revision of the GHS. It is not intended as a workplace or general OHS guidance document but is intended for expert classifiers and competent persons preparing safety data sheets. It is not expected that significant comment would be received by OHS generalists as a result. In addition, it is recommended that the draft Labelling Code also be examined for simple explanation of the GHS categories as they relate to labels. Safe Work Australia will be preparing guidance material for different audiences on the GHS and introducing two training courses (as basic and an expert one) to understand GHS classification. To facilitate the understanding of the draft Classification Criteria, Safe Work Australia has prepared two summary tables, comparing the classification classes and categories between the current dangerous goods and hazardous substances criteria (in the ADG Code and the Approved Criteria respectively) and the new GHS Classification Criteria. It should be noted that these summary tables are not part of the Classification Criteria but have been provided as additional guidance. For a full details of the new proposal go to the Safe Work Australia website.

Safe Work Australia, 6 October 2009

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~tNew U.S. EPA Review of Atrazine

~w2009-10-15

The Australian Pesticide and Veterinary Medicine Authority (APVMA) have said that it is aware of the United States Environmental Protection Agency (US EPA) plan to launch a comprehensive re-investigation of the health impacts of the herbicide atrazine. Atrazine is widely used on major crops in the USA, Australia and some 60 other countries. APVMA have been in contact with the Office of Pesticide Programs (OPP) within the US EPA and has been advised of its timetable for reviewing various aspects of the available data on atrazine. On 8 October, the US EPA provided detailed information on this review (details can be found at This review follows shortly after their extensive consideration of atrazine and reflects a political decision by the new US administration to re-visit a number of decisions made during the former administration.Australia has recently completed a comprehensive atrazine review.In addition to this comprehensive review, the APVMA decided to re-examine the more recent studies on atrazine. This project commenced in mid-2008 when the APVMA commissioned the Office of Chemical Safety and Environmental Health (OCSEH) (in the Australian Government Department of Health and Ageing) to consider new research on the biochemical actions of atrazine published in the scientific literature over the last few years. A key outcome of the OCSEH consideration will be to advise the APVMA whether any of these effects are relevant to the current human health risk assessment.A draft report has been received from OCSEH and will be peer-reviewed by an external scientific expert prior to it being published on the APVMA website.The APVMA will share this assessment with the US EPA as part of ongoing liaison between the agencies on issues related to pesticides regulation. In 2007, a detailed assessment of atrazine was conducted by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO). The assessment has recently been published as part of Pesticide Residues in Food 2007 ( This assessment concluded that the existing database on atrazine is adequate to characterise the potential hazards of atrazine to human health. Furthermore, it found that health-related exposure values can be established which are protective for the consequences of neuroendocrine and other adverse effects caused by prolonged exposure to atrazine and its metabolites.The APVMA plans to liaise with the US EPA as it conducts its further re-consideration and, if new information comes to light, will consider whether further regulatory action is warranted in Australia.

APVMA, 9 October 2009

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~tBill Introduced in Japan to Extend “REACH” of Chemical Substances Control Law

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Japan’s Ministry of the Environment announced in February that a bill to amend Japan’sChemical Substances Control Law (CSCL) was submitted to the 171st ordinary session of theDiet. The aim of the bill is to introduce a comprehensive control system to minimise the adverseeffects of chemical substances on human health and the environment and to ensure theinternational consistency of Japanese regulations on chemicals. The new bill will see the amendment of the CSCL, which would require companies that have manufactured orimported any chemical substance, including existing substances, in excess of specified amounts,to notify the government by application as to the quantity and other information relating to thesubstance. Upon receipt of an application, the government would screen and prioritisesubstances subject to detailed risk assessment. For these substances, manufacturers/importersmay be required to submit information on hazardous properties for government evaluation.Based on the evaluation, the government would then decide whether to regulate themanufacture/use of the substance.In recent years, public interest in safety and security, including ensuring the safety of chemicals,has increased in Japan. At the global level, an agreement was reached at the World Summit onSustainable Development in 2002 to minimise adverse effects of chemicals on human health andthe environment by 2020, and a new regulation on chemical substances – the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) scheme – entered into force inthe European Union (EU) in 2007. In addition, it is expected that additional chemicals will belisted under the Stockholm Convention to prohibit manufacture and use with specific exceptions.Thus, Japan has recognised that circumstances surrounding the control of chemicals havechanged in recent years. The bill at issue reflects Japan’s belief that it has yet to take sufficientmeasures in these regards. For example, risk assessments of many “existing chemicalsubstances” in Japan have yet to be completed.

Keller & Heckman, October 2009

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AMERICA

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~tOSHA issues proposed rule to adopt the Globally Harmonised Hazard Communication System

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In the 30 September Federal Register a proposed rule was published, which aligns the Occupational Safety and Health Administration's Hazard Communication Standard (HCS) with provisions of the United Nations Globally Harmonised System of Classification and Labelling of Chemicals (GHS). Under the current HCS, chemical manufacturers and importers are required to evaluate the hazards of the chemicals they produce or import and provide information to subsequent users. The current standard requires all employers to have a hazard communication program for workers exposed to hazardous chemicals. The program includes materials such as container labels, safety data sheets, and employee training. In a number of countries, including the United States, international organisations and stakeholders participated in developing the GHS to address inconsistencies in hazard classification and communications. The GHS was developed to provide a single, harmonised system to classify chemicals, labels and safety data sheets with the primary benefit of increasing the quality and consistency of information provided to workers, employers and chemical users. Under the GHS, labels would include signal words, pictograms, and hazard and precautionary statements. Additionally, information on safety data sheets would be presented in a designated order.'The proposal to align the hazard communication standard with the GHS will improve the consistency and effectiveness of hazard communications and reduce chemical-related injuries, illnesses and fatalities,' said acting Assistant Secretary of Labor for OSHA Jordan Barab. 'Following the GHS approach will increase workplace safety, facilitate international trade in chemicals, and generate cost savings from production efficiencies for firms that manufacture and use hazardous chemicals.'Under the Occupational Safety and Health Act of 1970, OSHA's role is to promote safe and healthful working conditions for America's men and women by setting and enforcing standards and providing training, outreach, and education.

Environmental Expert, 1 October 2009

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~tAgency Provides Guidance on Handling PCBs in Caulk

~w2009-10-15

The U.S. Environmental Protection Agency have announced a series of steps that building owners and school administrators should take to reduce exposure to PCBs that may be found in caulk in many buildings constructed or renovated between 1950 and 1978. in addition, the agency is conducting new research in order to better understand the risks posed by caulk containing PCBs. This research will guide EPA in making further recommendations on long-term measures to minimise exposure as well as steps to prioritise and carry out actions to remove the caulk to better protect public health. Polychlorinated biphenyls, or PCBs, are man-made chemicals that persist in the environment and were widely used in construction materials and electrical products prior to 1978. PCBs can affect the immune system, reproductive system, nervous system and endocrine system and are potentially cancer-causing if they build up in the body over long periods of time. “PCBs have been banned for the last 30 years for most uses,” said EPA Administrator Lisa P. Jackson. “But unfortunately, high levels of PCBs are present in many buildings and facilities constructed prior to the PCB ban, including most recently some schools. We’re concerned about the potential risks associated with exposure to these PCBs and we’re recommending practical, common-sense steps to reduce this exposure as we improve our understanding of the science. For building owners and administrators who want to take added and more aggressive immediate steps, EPA is providing additional guidance to help them identify the extent of potential risks and determine whether mitigation steps are necessary. Local communities and governments have constrained resources that make this a particularly challenging and sensitive situation.” The agency has created a website, with updated information on this issue.

While the manufacture and most uses of PCBs were banned in 1976 and phased out in 1978, there is evidence that many buildings across the country constructed or renovated from 1950 to 1978 may have PCBs at high levels in the caulk around windows and door frames, between masonry columns and in other masonry building materials. Exposure to these PCBs may occur as a result of their release from the caulk into the air, dust, surrounding surfaces and soil and through direct contact. EPA has calculated prudent public health levels that maintain PCB exposures below the “reference dose” – the amount of PCB exposure that EPA does not believe will cause harm. Those levels vary depending on the age group and use assumptions about potential PCB exposures from other sources, such as diet. Although this is a serious issue, the potential presence of PCBs in buildings should not be a cause for alarm. If buildings were erected or renovated between 1950 and 1978, EPA recommends that owners implement steps to minimise exposure to potentially contaminated caulk in the following ways:

Cleaning air ducts

Improving ventilation by opening windows and using or installing exhaust fans where possible

Cleaning frequently to reduce dust and residue inside buildings

Using a wet or damp cloth or mop to clean surfaces

Not sweeping with dry brooms and minimising the use of dusters in areas near potential PCB-containing caulk

Using vacuums with high efficiency particulate air filters

Washing hands with soap and water often, particularly before eating and drinking

Washing children’s toys often

In addition, recommends testing peeling, brittle, cracking or deteriorating caulk directly for the presence of PCBs and removing the caulk if PCBs are present at significant levels. Alternately, the building owner can assume the PCBs are present and proceed directly to remove deteriorating caulk. Building owners and facility managers should also consider testing to determine if PCB levels in the air exceed EPA’s suggested public health levels. If testing reveals PCBs in the air above these levels, building owners should be especially vigilant in implementing and monitoring ventilation and hygienic practices to minimise exposures. Owners and managers are encouraged to retest PCB levels in air to determine whether these practices are reducing the potential for PCB exposures. Should these practices not reduce exposure, caulk and other known sources of PCBs should be removed as soon as practicable. There are several unresolved scientific issues that must be better understood to assess the magnitude of the problem and identify the best long-term solutions. For example, the link between the concentrations of PCBs in caulk and PCBs in the air or dust is not well understood. The agency is doing research to determine the sources and levels of PCBs in buildings in the United States and to evaluate different strategies to reduce exposures. The results of this research will be used to provide further guidance to building owners as they develop and implement long-term solutions. Where buildings were constructed or renovated between 1950 and 1978, EPA recommends that PCB-containing caulk be removed during planned renovations and repairs (when replacing windows, doors, roofs, ventilation, etc.). It is critically important to ensure that PCBs are not released to the air during replacement or repair of caulk in affected buildings.

Environmental Protection News, 30 September 2009

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~tAgency Adopts New Strategy for Nanomaterial Research

~w2009-10-15

The U.S. Environmental Protection Agency has revealed a new research strategy to better understand how manufactured nanomaterials may harm human health and the environment. Nanomaterials are materials that are between approximately one and 100 nanometers. A nanometer is approximately 1/100,000 the width of a human hair. These materials are currently used in hundreds of consumer products, including sunscreen, cosmetics and sports equipment.The strategy details what research EPA will support over the next several years to generate information regarding the safe use of nanotechnology and products that contain nano-scale materials. In addition, the strategy includes research into ways nanotechnology can be used to clean up toxic chemicals in the environment.EPA’s role among federal agencies is to determine the potential hazards of nanotechnology and develop approaches to reduce or minimise any risks identified. As part of the strategy, researchers are investigating widely used nanomaterials, such as carbon nanotubes, which are used in vehicles, sports equipment and electronics; and titanium dioxide, which are used in paints, cosmetics and sunscreens. The research is being conducted in EPA’s own laboratories and by grant recipients as part of a collaborative effort with other federal organisations and the international community. EPA’s research is conducted using a multidisciplinary approach that examines all aspects of nanomaterials in the environment, from their manufacture and use to their disposal or recycling. EPA’s new nanotechnology Web site provides more details about the research and offers news and publications.