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June 3, 2011
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*While Chemwatch has taken all efforts to ensure the accuracy of information in this publication, it is not intended to be comprehensive or to render advice. Websites rendered are subject to change.
Emergency Permits for Mouse Baits
Some states are experiencing mouse plagues. Farmers are faced with extensive mouse control programs to protect crops. There is an effective vertebrate poison product registered for mice control on the market. However, farmers argue that it is too expensive. In addition, some have expressed the view that supplies of it are limited. Accordingly, they have supported an Emergency Use Permit (EUP) application to the Australian Pesticide and Veterinary Medicine Authority (APVMA) to allow on-farm mixing of the active constituent (zinc phosphide) with grain. An emergency use permit provides authority to use an unregistered product or active constituent (or one registered for a different purpose) in an emergency situation. An emergency situation is loosely defined in the APVMA legislation as one where there is a genuinely believed need for the use of the product or constituent. Because the definition is broad, the APVMA has developed broad policies to guide action. These include the principle that an EUP is time-limited to address a need, will generally not be issued when there is product registered for the proposed use with good availability, and that EUPs will generally not be issued on the basis of a cost preference. These matters aside, in considering a permit application the APVMA must be satisfied that the use of the product concerned will be safe in terms of human health, the environment, trade and occupational health and safety (OHS). Supporting data relating to the proposed use must be supplied with the application for the APVMA to make an assessment. The APVMA has been involved in many discussions with farmer groups, state government officials and registrants over several months on mice control issues.
In these discussions a range of zinc phosphide options have been discussed including the use of unsterilised grain (to make the product cheaper), regional bait mixing stations as well as the idea of on-farm mixing. The APVMA has consistently raised the issue that, apart from the policy issues, the major concern with any option that involved farmers mixing the product themselves is ensuring operator and bystander safety. Zinc phosphide is a Schedule 7 poison. This is the highest level of scheduling and substances with this scheduling level are labelled as ‘dangerous poisons’. There are access restrictions to Schedule 7 poisons at state level, but even then, there are very real OHS concerns. On this basis, the APVMA advised that any permit application that involved on farm application would need extensive data from reputable studies that could demonstrate that the health risks could be effectively managed. Furthermore, the APVMA advised that it would have less concerns if the states or grower groups could develop regional bait mixing stations where risks to operators and bystanders could be more effectively controlled. An emergency use permit for on-farm mixing of zinc phosphide with grain was received and accepted on Thursday 5 May. The permit is being assessed. Discussions with stakeholders about the application and alternative options are ongoing.
APVMA, 13 May 2011 http://www.apvma.gov.au
Preliminary announcement on agvet chemicals regulation reform
In 2010, the Australian Government identified the regulation of agricultural and veterinary (agvet) chemicals as an important area of reform. In a post-budget breakfast speech on Wednesday 11 May, Senator the Hon. Joe Ludwig, Minister for Agriculture, Fisheries and Forestry provided initial details of the reform to agvet chemical regulation in Australia. This follows consultation on the November 2010 policy discussion paper, Better Regulation of Agricultural and Veterinary Chemicals. While the reform focuses on a range of areas, the Minister’s speech gave an insight into three of the reform outcomes:
Implementing complete risk frameworks for agvet chemicals assessment and review
A comprehensive, publicly available risk framework will be introduced. This will increase transparency in the system and further allow industry and the APVMA to target risk using limited resources, more effectively.
Improving the quality and efficiency of agvet chemical assessment and registration processes
The Government will establish clear legislated timeframes for the completion of assessments and reviews to provide certainty to business and the community about review periods. The Government will also look at ways to strengthen data protection for new applications.
Enhancing the agvet chemical review arrangements
A re-registration system will be introduced. The process will be commenced by releasing draft legislation for consultation in the coming months. This will propose a three-staged approach to re-registration, which will ensure resources within industry and the APVMA are focused on those chemicals with the highest risk. Improved data protection will also be provided under the re-registration system.
The APVMA and the Department of Agriculture, Fisheries and Forestry are continuing to inform the policy development process and preparing to develop processes to implement the Government’s reforms once the specific nature of the reforms has been announced.
APVMA, 13 May 2011 http://www.apvma.gov.au
Safe Work Australia publishes report on carbon nanotubes
Safe Work Australia Chair, Mr Tom Phillips AM, recently announced the release of a research report: Durability of carbon nanotubes and their potential to cause inflammation. The structural similarities of some forms of carbon nanotubes with asbestos have raised concerns regarding possible health effects for humans. This study examined the durability of carbon nanotubes and the tendency to cause lung inflammation, two indicators of potential asbestos-like behaviour, if inhaled. Commissioned under the Nanotechnology Work Health and Safety Program and funded by the Department of Innovation, Industry, Science and Research, the Commonwealth Scientific and Industrial Research Organisation (CSIRO), the University of Edinburgh in the United Kingdom (UK) and the UK Institute of Occupational Medicine undertook this experimental research. The major findings from the study included:
Some types of carbon nanotubes can be durable, but others may also break down in simulated lung fluid.
Carbon nanotubes of certain length and aspect ratio can induce asbestos-like responses in mice, confirming previous findings. However, this response may be reduced if the nanotubes are less durable.
Tightly agglomerated particle-like bundles of carbon nanotubes did not cause an inflammatory response in mice.
Shorter carbon nanotubes or bundles of carbon nanotubes may not be an asbestos-like hazard, but they can still cause an inflammatory response and be hazardous in the lungs.
“This project is an excellent example of Australia and the United Kingdom collaborating to undertake world class work health and safety research”, said Mr Phillips. “These results indicate that durability and hazards of all types of carbon nanotubes are not necessarily the same. However carbon nanotubes should be handled with high levels of caution in the workplace to avoid inhalation. Safe Work Australia continues to support research on carbon nanotubes to further the knowledge of work health and safety issues, and has commissioned other work which uses the research findings to protect workers. A copy of the research report is available at: http://www.safeworkaustralia.gov.au/AboutSafeWorkAustralia/WhatWeDo/Publications/Pages/DurabilityCarbonNanotubes.aspx
Safe Work Australia, 12 May 2011 http://www.safeworkaustralia.gov.au
Japan’s New Chemical Reporting Requirements
On 1 April 2011, a new reporting requirement for chemicals came into effect in Japan. This new requirement originated in the 2009 amendment to Japan’s chemical control law and requires that companies submit an annual report on chemical substances manufactured or imported into Japan. The first round of reports must be submitted by 30 June 2011, to the Ministry of Economy, Trade and Industry (METI). The primary chemical control law in Japan is the Law Concerning the Examination and Regulation of Manufacture, etc., of Chemical Substances (Law No. 117 of October 16, 1973). The law was most recently amended in 2009 to add, among other things, an annual reporting requirement. The new scheme imposes a reporting obligation on companies manufacturing or importing more than one metric ton of a “general chemical substance” or a substance designated as a “priority assessment chemical substance” (PACS). METI has issued a list of chemical substances designated as PACSs as of 1 April 2011, available at: http://www.meti.go.jp/policy/chemical_management/english/files/PACSs-list.pdf
When METI receives a report, or notification, it will conduct a screening evaluation designed to identify any additional chemicals that should be classified as PACSs. Any substance selected as a PACS will undergo a risk assessment by METI, and the Ministry may require its manufacturer or importer to submit information on the substance’s hazardous properties. Depending on the outcome of the assessment, METI may restrict the manufacture or use of the substance. The notification must state the identity of the chemical substance and, if known, its Chemical Abstract Services Registry Number (CASRN). The notification must include the amount of the substance that was manufactured or imported during the previous calendar year, rounded to one significant digit. For example, 12,499 metric tons should be rounded to 10,000 metric tons, and 1,894 metric tons should be rounded to 2,000. Finally, the notification should specify the use of the substance, selected from one of the use categories provided by METI. On 8 February 2011, METI released an updated list of use categories, which is available at: http://www.meti.go.jp/policy/chemical_management/english/files/use%20category.pdf
For general chemical substances, companies must use notification Form 11. For PACSs, companies must use Form 12. The notification form may be submitted by paper, electronically, or by CD. METI is developing software that will enable companies to generate notification documents electronically, and it plans to make this software available free of charge. The notification must be submitted annually to METI between 1 April and 30 June. As explained above, the reporting requirement applies to chemical substances that are manufactured or imported in quantities of at least one metric ton per year.
Certain substances determined not to be persistent or bioaccumulative are only subject to the reporting requirement if manufactured or imported in quantities of at least 10 metric tons. Note that “existing” chemical substances are subject to the reporting requirement. The law does exempt the following types of substances from reporting:
Naturally-occurring substances, including substances that degrade exclusively into ions (e.g., sodium chloride), and substances that are essential to biotic activity (e.g., citric acid).
Substances regulated under other laws (e.g., gasoline, which is regulated under the Act Concerning the Maintenance of Quality of Gasoline).
Substances that are domestically purchased and either (1) sold “as is” or (2) processed in a way that does not cause a chemical reaction.
Substances imported for research and development (R&D) purposes.
Imported “products” sold to general customers.
A new chemical substance that is confirmed as a polymer of low concern (PLC) by the Minister of Health, Labor, and Welfare, the Minister of Economy, Trade, and Industry, and the Minister of Environment. There are two types of polymers that are eligible for this exemption:
A substance whose number average molecular weight is 1,000 or more.
Any chemical substance composed of an aggregation of molecules that are produced by linkages of one or more types of monomeric units, in which the total weight of those molecules that are composed of three or more linkages makes up 50% or more of the weight of the whole substance, and the total weight of those molecules with identical molecular weight is less than 50% of the weight of the whole substance.
Additional polymers that are exempt from reporting:
Polymers that received a determination equivalent to a non-hazardous determination under the High Molecular Flow Scheme, between April 1987 and March 2004. This exemption is limited to polymers that have no risk of ecological impact.
Polymers that received a determination equivalent to a non-hazardous determination under the High Molecular Flow Scheme starting in April 2004. This exemption is limited to polymers that were specifically announced.
Existing chemical substances that are recognised as equivalent to non-hazardous determination under the High Molecular Flow Scheme.
Substances that are considered intermediates, as confirmed by the three Ministers listed above.
Substances that are specifically exempted by METI.
METI plans to annually update the list of exempt substances.
Further information on the guidance is available at:
Keller and Heckman, 17 May 2011 http://www.khlaw.com
EPA Announces Next Step on Air Toxics Standards for Boilers and Certain Incinerators/Agency allows time to seek and review additional public input on new standards
The U.S. Environmental Protection Agency (EPA) is seeking additional public feedback and is gathering more information on the final standards for boilers and certain solid waste incinerators that were issued in February 2011. These additional opportunities for public input will ensure that any final standard will be informed by input and feedback from key stakeholders, including the public, industry, and public health communities. Input through the public comment process already resulted in dramatic cuts in the cost of implementation, while maintaining maximum public health benefits, under the rule announced in February. As part of the reconsideration process, EPA will issue a stay postponing the effective date of the standards for major source boilers and commercial and industrial solid waste incinerators to allow the agency to continue to seek additional public comment before an updated rule is proposed. This process of careful consideration of public comments, and close attention to both costs and benefits, is consistent with the president’s directives with respect to regulation, as set out in executive order 13563, issued on 18 January. Following the April 2010 proposals, the agency received more than 4,800 comments from businesses and communities, including a significant amount of information that industry had not provided prior to the proposals. Based on this input, EPA made extensive revisions to the standards, and in December 2010 requested additional time for review to ensure the public’s input was fully addressed. The court only granted EPA 30 days, resulting in the February 2011 final rules. The agency is reconsidering the standards because the public did not have sufficient opportunity to comment on these changes, and, as a result, further public review and feedback is needed. EPA will accept additional data and information on these standards until 15 July 2011. Further information is available at: http://www.epa.gov/airquality/combustion
EPA, 16 May 2011 http://www.epa.gov