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February 25, 2011
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Transparency review public meetings: Schedule and registration
The Panel undertaking the Review to Improve Transparency of the Therapeutic Goods Administration (TGA) have organised the following meetings to listen to public comments. The Panel has been asked to report on:
opportunities to provide more information about products on the market;
how the public can improve its understanding of the ways new products are assessed and products on the market are monitored;
the timing for making information available about new products;
the type of information and how it is made public by comparable overseas regulators;
constraints (or barriers) to the release of further information, such as implications for public health and safety;
how the material can be published - e.g. use of the internet and other publication methods; and
Opportunities for the public to access more information about the advertising of therapeutic goods.
During these meetings, the panel will be seeking to determine the types of information that participants believe the TGA should make available, and the ways you would like to receive that information. The meetings will include the opportunity for participants to share views with all attendees on the Review, and for discussion in small groups chaired by a member of the Panel. Details of the meeting to be held are as follows:
For details of how to register for one of the meeting go to the TGA website: http://www.tga.gov.au/newsroom/consult-transparency-review-public-meetings.htm
TGA, 2 February 2011 http://www.tga.gov.au/
Unsafe products permanently banned under Australian Consumer Law
On 8 February 2011, Parliamentary Secretary to the Treasurer, David Bradbury announced that cigarette lighters that look like children’s toys and ‘sky lanterns’ are among the first 10 permanent product bans made under the new Australian Consumer Law. The products, which were initially the subject of 18 month interim bans, have now been permanently banned in all States and Territories. “These are the first permanent bans under the new Australian Consumer Law and will help to keep consumers safe from potentially hazardous products,” said Mr Bradbury. “Under the new national product safety system, these bans will be in force uniformly in all States and Territories.” The bans include seven products that were identified by the Commonwealth, States and Territories through a process last year to harmonise product safety regulations in Australia, while a further three products were recommended for permanent bans by the Australian Competition and Consumer Commission (ACCC). “The products that have now been permanently banned under the Australian Consumer Law include cigarette lighters that look like children’s toys, infant food containers and toys that contain more than 1% of the chemical diethylhexyl phthalate (DEHP), and unmanned hot air balloons, or ‘sky lanterns’. “These permanent bans will ensure that consumers, particularly children, are protected from products that may cause them serious harm. “A supplier of goods that are found to be in breach of these bans can be prosecuted and fined up to $1.1 million and can also be required to recall the goods at their expense.” The new Australian Consumer Law, came into effect on 1 January 2011, and allows for permanent bans and standards made by the Commonwealth to have effect in all States and Territories. “The Commonwealth has worked with the States and Territories to develop a national product safety system, so that products deemed to be unsafe are subject to bans or standards consistently across the country, enforced by State and Territory as well as Commonwealth regulators,” said Mr Bradbury. “A national product safety system also cuts down on red tape for businesses that operate in more than one State and Territory. Under the new Australian Consumer Law, businesses only have one set of product safety regulations to comply with, making it easier to operate across State and Territory borders.” Further information can be found at: www.productsafety.gov.au.
Products subject to new permanent bans
Product Safety Australia, 8 February 2011 http://www.productsafety.gov.au
Submissions sought on insecticides acephate and methamidophos
New Zealand’s Environmental Risk Management Authority (ERMA) is calling for submissions on a proposal to phase out the use of the insecticides acephate and methamidophos. Acephate and methamidophos are organophosphates used on crops such as avocados, citrus, boysenberries, potatoes, onions, sweetcorn, tomatoes and brassicas. In addition, they are used to treat imported seeds, nursery stock and cut flowers. Their reassessment is part of a wider review of organophosphates used in New Zealand and internationally. Reassessments in Europe, the United States, Canada and other countries have resulted in the substances being restricted, voluntarily removed from sale or prohibited. Currently, six formulations of acephate and three of methamidophos are approved for use in New Zealand. In its preliminary recommendation, ERMA New Zealand states that both substances carry potential risks to operators, workers, bystanders and the environment. It is recommending the approvals for both substances be revoked, with a suitable phase-out period. ERMA has requested that interested parties lodge a submission. Upon receiving all submissions, the agency may hold a hearing prior to the committee making a decision. All submissions must be received by 16 March 2011. Further details can be found at: http://www.ermanz.govt.nz/Publications/ERMA200399-Application-Form.pdf
ERMA, 2 February 2011 http://www.ermanz.govt.nz
SOCMA Renews Call for Long-term CFATS
The Society of Chemical Manufacturers and Affiliates (SOCMA), has released a statement to a key House Homeland Security Subcommittee, calling for swift congressional action to pass a three-to-five year authorisation of Chemical Facility Anti-Terrorism Standards (CFATS) that will expire 4 March. The hearing, held before the Subcommittee on Cybersecurity, Infrastructure Protection and Security Technologies, included witnesses from Department of Homeland Security (DHS), the chemical manufacturing industry, and academia who spoke on the effectiveness of the current standards, the status of their implementation, and legislative recommendations for Congress. Timothy Scott, chief security officer for SOCMA member company Dow Chemical, was among the witnesses. “The need for annual reauthorisation of the program has created uncertainty for the chemical industry, which is making large financial investments in tools and technology in order to comply with the current CFATS standards,” SOCMA President Lawrence D. Sloan wrote. “Without the assurance of a long-term authorisation of chemical security regulations, companies run a risk of investing in costly activities today that might not satisfy regulatory standards tomorrow.” Sloan cited the importance of implementing the program from start to finish, which would provide both DHS and chemical companies the ability to assess the overall efficacy of CFATS, identify its areas of strength and weakness, and subsequently make (or recommend to Congress) any necessary improvements. He additionally reiterated SOCMA’s steadfast opposition to provisions included in House-passed legislation from the 111th Congress that would have required chemical facilities to use “inherently safer technologies” in their processes. On April 13, SOCMA members will directly take their message to Congress and discuss their position with lawmakers and their staff during SOCMA Connect’s 4th Annual Washington Fly-in.
Environmental Protection News, 12 February 2011 http://www.eponline.com
EPA Naming Secret Names
According to the EPA, companies are improperly claiming chemicals’ identities as confidential. In a new move, the EPA has announced that it plans to release the identities of 14 chemicals that were claimed as trade secrets in toxicity studies required to be submitted to the agency under the Toxic Substances Control Act (TSCA). On 10 February, the agency sent letters to five chemical manufacturers warning them it will release the identities of the substances to the public in mid-March. However, EPA will defer its actions if the companies file a challenge in federal court. The five companies are Givaudan Fragrances, Japan Technical Information Center, JSR Micro, Nalco, and Promerus LLC. As part of health and safety studies sent to EPA, the companies claimed the names of their substances as confidential business information, the agency says. EPA employees and contractors face threat of criminal prosecution if they release data claimed as confidential under that law. A year ago, the agency announced it would crack down on improper secrecy claims for the identity of chemicals in health and safety studies sent to the agency. TSCA tightly limits confidentiality assertions for chemical identities in these studies, though companies in the past have often made such claims. “The public deserves access to critical health and safety information on chemicals, but if the name of the chemical is kept secret in the health and safety report, the information is of no real value to people,” said Steven Owens, EPA assistant administrator for chemical safety and pollution prevention. EPA says it plans to warn more companies and release more names of chemicals improperly claimed as confidential in health and safety studies.
Chemical & Engineering News, 11 February 2011 http://pubs.acs.org/cen/news
Congress Restarts Plant Security Debate
On 11 February 2011, a chemical industry official told a congressional panel that the current federal program for securing the nation’s chemical facilities against potential terrorist attacks is working well and should be permanently extended without any major modifications. The Chemical Facility Antiterrorism Standards (CFATS) program established by the Department of Homeland Security (DHS) in 2007 is “demonstrably achieving its objectives,” Timothy J. Scott, chief security officer of Dow Chemical, said in testimony before the House Subcommittee on Cybersecurity, Infrastructure Protection & Security Technologies. Scott said CFATS, which is a temporary program that must be reauthorised this year, drives facilities to consider all risk-reduction options, including process safety improvements, when developing a site security plans. “These tough regulations are yielding measurable results to manage or in some cases eliminate security risks,” Scott testified. “It’s important that we don’t lose this momentum.” Rep. Daniel E. Lungren (R-Calif.), subcommittee chairman, said the best way to bolster security at chemical facilities is to allow DHS to fully implement CFATS before any significant program changes are enacted. “We’re not looking at a complete overhaul,” he said. The Obama Administration, with the strong support of environmental groups, wants Congress to give DHS the authority to require facilities that make or use the most dangerous chemicals to adopt inherently safer technology (IST), such as switching to less toxic alternative substances. Rep. Yvette D. Clarke of New York, the panel’s ranking Democrat, said “inherently safer practices do work, are well understood, and can significantly increase security by reducing consequences of a release of chemicals.” However, Lungren said he would oppose such a requirement. “I don’t support a single-solution security approach,” he remarked. “It should not be mandated. There is no single definition of what IST is.” An IST mandate would add an “unacceptable degree of uncertainty” to CFATS and place an “unjustifiably large burden” on chemical facilities and DHS, said Scott, who testified on behalf of the American Chemistry Council, an industry trade association. Sam Mannan, a Texas A&M University chemical engineering professor, warned that U.S. facilities could be at a competitive disadvantage “if required to implement unproven technologies simply to meet a regulator’s position that such technology is more inherently safe.”
Chemical & Engineering News, 15 February 2011 http://pubs.acs.org/cen/news
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