Proposed registration of the new active mandipropamid in the product Revus Fungicide




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Bulletin Board

June 10, 2011


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Legislation

ASIA PACIFIC

Proposed registration of the new active mandipropamid in the product Revus Fungicide

2011-06-01

The Australian Pesticide and Veterinary Medicine Authority (APVMA) have invited interested parties to submit comment on the registration of the new active mandipropamid in the product Revus Fungicide. Comments will be received until 21 June 2011. Further details are available at: http://www.apvma.gov.au/consultation/public/prs_mandipropamid.php

APVMA Regulatory Update, 27 May 2011 http://www.apvma.gov.au


FSANZ calls for comment on horticulture paper

2011-06-01

Recently, Food Standards Australia New Zealand (FSANZ) released a consultation paper on what approaches should be taken to ensure food safety in fresh horticultural produce. FSANZ Chief Executive Officer, Steve McCutcheon, said Australians had access to a large variety of high quality, safe fresh produce. “Surveys conducted by FSANZ over many years have demonstrated that the Australian horticulture sector does a good job in managing the food safety risks associated with fresh produce,” Mr McCutcheon said. “However, from time to time, microbiological or chemical hazards can arise and these can present a risk to the consumer. “The horticulture industries in Australia have been quick to implement measures through audited industry schemes or other systems that address food safety. What we don’t know is whether these measures are sufficient to provide a nationally consistent approach to food safety across the entire sector.” According to Mr McCutcheon, FSANZ was now working with industry to establish whether current measures are adequate to ensure the safety of fresh produce or whether new national requirements need to be developed. “FSANZ’s key responsibility is the protection of public health and safety and we do this using the best available scientific evidence while promoting consistency between domestic and international food standards. “We intend to consult widely as this work progresses and we acknowledge that there are a large number of growers, packers, wholesalers and industry bodies as well as other non-industry stakeholders that will wish to contribute. We will be working to establish communication links with all those involved in the sector.” The proposal is now open for comment. Written submissions must be lodged with FSANZ by 11 July 2011. To view consultation paper go to: http://www.foodstandards.gov.au/_srcfiles/Horticulture%20Produce%20Consultation%20paper%20FINAL.pdf

FSANZ, 31 May 2011 http://www.foodstandards.gov.au


Guidance on the GMP clearance of overseas medicine manufacturers

2011-06-01

The Therapeutic Goods Act 1989 (the Act) requires that the standard of manufacture, and quality control of therapeutic goods manufactured outside Australia, be taken into consideration for the registration or listing of those therapeutic goods on the Australian Register of Therapeutic Goods (ARTG), unless the goods are exempt from this requirement by the Act. A sponsor applying to the Therapeutic Goods Administration (TGA) for registration or listing of a therapeutic good manufactured outside Australia, must provide an acceptable form of evidence to show that the manufacture of the goods is of an acceptable standard. This is referred to as Good Manufacturing Practice (GMP) clearance of overseas manufacturers. The TGA have recently released guidance on the GMP clearance of overseas medicine manufacturers. The aim of this document is twofold. It is intended to provide information to sponsors and manufacturers on the acceptable form of evidence of GMP compliance for overseas manufacturers, and, outline how to submit such evidence to the TGA for assessment. It is not intended to provide a definitive list of the forms of evidence that are considered acceptable or unacceptable. The Australian Regulatory Guidelines Good Manufacturing Practice (GMP) Clearance for Overseas Manufacturers (17th edition) will be phased in over the next 3 months. During this period, submitted applications for GMP Clearance may the requirements of either the preceding 16th or 17th edition. At the conclusion of the phase-in period (15 August 2011) the preceding 16th edition of the guidelines will be retired. Subsequent applications after this date will be required to meet the requirements of the 17th edition of the guidance. To view a copy of the guidance document go to: http://www.tga.gov.au/pdf/manuf-overseas-medicines-gmp-clearance-17.pdf

Therapeutic Goods Administration, 16 May 2011 http://www.tga.gov.au/


Authority revokes approvals for fungicide quintozene

2011-06-01

New Zealand’s Environmental Risk Management Authority (ERMA) has revoked the approvals for the fungicide quintozene, due to dioxin impurities. Quintozene is used commercially on seedlings, bulbs and recreational turf in New Zealand. The decision to review the substance came after dioxin impurities were found in quintozene products in Australia at levels that may have presented health risks to workers who frequently applied them. Dioxins are on the list of substances covered by the Stockholm Convention on Persistent Organic Pollutants. As a party to the Convention, New Zealand is committed to reducing releases of dioxin to the environment. Only one quintozene-containing product, Terraclor 75 WP, is registered in New Zealand. Importer Nufarm took steps to ensure no new stock was imported or sold during the reassessment and stocks are believed to be minimal. ERMA New Zealand Hazardous Substances General Manager Andrea Eng congratulated Nufarm on its responsible approach. In making its decision, the Authority found that the health and environmental risks associated with the use of quintozene, based on both the active ingredient and the dioxin contaminant, outweighed the benefits of its use. The decision to discontinue the use of quintozene is also consistent with New Zealand’s commitment to the Stockholm Convention. The Authority revoked the approvals for import and manufacture, effective immediately, with any unused stock to be disposed of within three months. Arrangements are under way to safely handle and dispose of unused stock. Importer and supplier Nufarm will accept unopened containers of quintozene which it will return to the US manufacturer, while rural recycling programme Agrecovery has committed to collecting and disposing of any surplus stock.

NZ Environmental Risk Management Authority, 26 May 2011 http://www.ermanz.govt.nz


Philippines FDA reassures public over DEHP in food products

2011-06-01

The head of the Philippines’ Food and Drug Administration has sought to reassure the public that food products and food additives imported from Taiwan are being monitored after the Taipei Economic and Cultural Office (TECO) told the Philippine government that a company may have imported food products containing additives contaminated by the phthalate DEHP to the Philippines. Efforts to trace local counterpart of this company are currently in progress. According to the Philippine Department of Health, DEHP was found to be illegally added to a food product raw material intended for emulsification. “While low doses of DEHP are generally safe,” said the department, “high doses or prolonged exposure can have harmful effects. Children are especially prone to the harmful effects of high doses of DEHP or to repeated exposure which can lead to testicular effects, fertility problems and toxicity to kidneys.” In recent weeks the Taiwanese authorities have made a number of public statements regarding the results of investigations into phthalate levels and labelling of cosmetics and children’s products.

Chemical Watch, 27 May 2011 http://chemicalwatch.com/news


AMERICA

Texas Passes First Fracking Disclosure Bill

2011-06-01

On 25 May, Texas lawmakers passed its version of House Bill 3328, which requires natural gas drillers to disclose the chemicals used during the fracking process. Hydraulic fracturing is a process associated with deep natural gas extraction. Millions of gallons of water, sand and chemicals are injected, under high pressure, into a well. The pressure fractures the shale and opens fissures that enable natural gas to flow more freely out of the well. Typically, 80 to 300 tons of chemicals may be used. Environmentalists and the public have fought for the disclosure of these chemicals, claiming they have a right to know whether these chemicals are polluting groundwater. For the most part, natural gas drilling companies have fought against disclosing these chemicals -- until now. Under the new bill, drilling companies will be required to disclose 100-percent of the chemicals well by well, location by location, and post the list on a website. Because of changes to the bill, it will likely require a conference committee to reconcile the differences. The following is a statement from Scott Anderson, senior policy adviser at Environmental Defence Fund: “This bill represents a positive step. Industry needs to reassure the public regarding its actions and this will help. While it isn’t the model we had hoped for, it will help move disclosure efforts forward across the country and globe; and will hopefully put the industry closer to full, mandatory disclosure.”

Environmental Protection News, 26 May 2011 http://www.eponline.com


Requests for Modification or Revocation of Toxic Substances Control Act Section 5 Significant New Use Notice Requirements; Revision to Notification Regulations

2011-06-01

On 27 May 2011, the U.S Environmental Protection Agency (EPA) published a direct final rule which amends the procedures for requests for modification or revocation of Toxic Substances Control Act (TSCA) section 5 significant new use notification (SNUN) requirements by establishing electronic submission requirements. EPA issued a final rule in the Federal Register of 6 January 2010; introducing electronic reporting requirements for TSCA section 5 submissions and supporting documents. However, the regulatory text inadvertently did not include amendments to the reporting requirements for submissions of requests for modifications or revocations of SNUN requirements. This direct final rule includes the amendment that was originally intended by EPA. This direct final rule is effective from 26 July 2011 without further notice, unless EPA receives adverse comment on or before 27 June 2011. If EPA receives adverse comments on this action, it will withdraw the direct final rule before its effective date. The agency will then issue a proposed rule, providing a 30-day period for public comment.

Federal Register, 27 May 2011 http://www.gpoaccess.gov/fr


Federal scientists find BPA contamination in the majority of US canned foods

2011-06-01

Scientists from the US Food and Drug Administration (FDA) have published the findings of a study on the bisphenol A (BPA) concentration in popular canned foods from the US market, which found that BPA had contaminated over 90% of the food sampled. In the new study, published in the Journal of Agricultural and Food Chemistry, the researchers report the presence of BPA in 71 out of 78 samples of canned goods tested. They found no trace of the chemical in two samples of frozen food sold in plastic bags, which they tested as a control. The results demonstrated significant variations in BPA concentration, even between different products of the same food type and between different lots of the same product. Store brands were not necessarily more tainted than name brand products, nor were organic foods reliably cleaner than conventional products. The federal scientists concluded, ‘There are few clear trends in the data,’ with the only distinguishable pattern being that fruits and tuna showed the lowest BPA concentrations. Full details of the study are available at: http://pubs.acs.org/doi/pdf/10.1021/jf201076f

Chemical Watch, 30 May 2011 http://chemicalwatch.com/news


US state limits cadmium in children’s jewellery

2011-06-01

The US state of Maryland has enacted a law limiting the total amount of cadmium in children’s jewellery. The restriction comes into force 1 July 2012, after which children’s jewellery exceeding the 75 ppm total cadmium limit may not be manufactured, sold, offered for sale, or distributed in Maryland. Further details on the new legislation is available at: http://mlis.state.md.us/2011rs/bills/hb/hb0145e.pdf

Chemical Watch, 27 May 2011 http://chemicalwatch.com/news


California bill to restrict BPA in baby products progresses

2011-06-01

The US Californian Assembly has passed a bill to limit the amount of bisphenol A (BPA) in infant products including baby bottles. The bill will now go before the state Senate for consideration, and if passed the new restrictions would enter into effect in July 2013. Details of the new bill are available at: http://e-lobbyist.com/gaits/text/290569

Chemical Watch, 25 May 2011 http://chemicalwatch.com/news


Release of Final Interpretive Guideline No. 2011-001 Hand-To-Mouth Transfer of Lead Through Exposure to Consumer Products

2011-06-01

California’s Office of Environmental Health Hazard Assessment (OEHHA) recently announced the release of the Interpretive Guideline No. 2011-001: Guideline for Hand-to-Mouth Transfer of Lead through Exposure to Consumer Products. Within the context of Proposition 65, the Interpretive Guideline provides general scientific guidance on how to estimate lead intake from the handling of consumer products. A copy of the Interpretive Guideline can be obtained from the OEHHA web site at http://www.oehha.ca.gov/prop65.html.

California Office of Environmental Health Hazard Assessment, 31 May 2011 http://www.oehha.ca.gov


Sweeping OHS bill passes in Ontario

2011-06-01

After months of debate and consultation, Bill 160 has passed in Ontario, Canada after a recent vote in the provincial assembly. The Occupational Health and Safety Statute Law Amendment Act will take full effect when it achieves Royal Assent, as soon as next month. The Act will create the position of a provincial Chief Prevention Officer as well as a Prevention Council to work with the Ministry of Labour to develop a comprehensive occupational health and safety strategy and determine training standards. The act will affect almost all businesses across the province. Establishing province-wide training standards will be central to the Act after it becomes law. Further details can be found at: http://ontarioohsreform.ohsinsider.com/ontario-ohs-reform-alerts/alert-it%E2%80%99s-official%E2%80%94bill-160-is-passed

Environmental Expert, 26 May 2011 http://www.environmental-expert.com


EUROPE

New web section on “Risk Assessment of Biocides” now available

2011-06-01

Find updated content and documentation previously hosted by the (ex) European Chemicals Bureau web site. A new web section dedicated to ‘Risk Assessment of Biocides’ has been integrated into the Institute for Health & Consumer Protection (IHCP) site. Replacing the IHCP section dedicated to ‘Risk Assessment of Chemicals’, it now includes detailed documentation hosted by the former European Chemicals Bureau (ECB) web site (Biocides section http://ecb.jrc.ec.europa.eu/biocides/, which will be soon discontinued).

The biocides work area managed by the JRC-IHCP (Institute for Health and Consumer Protection) provides technical and scientific support to Member States’ Competent (CAs) Authorities and the European Commission with respect to the implementation of the Biocidal Products Directive (BPD) 98/8/EC on the placing on the market of biocidal products, which entered into force on 14 May 2000. The Directive defines biocidal products and sets out the frame for their evaluation in a two step procedure where the first step is the entry of the active substances into Annex I (IA or IB) and the second step is the authorisation of the products in which the active substances are used. To access new web section go to: http://ihcp.jrc.ec.europa.eu/our_activities/health-env/risk_assessment_of_Biocides/new-web-section-on-risk-assessment-of-biocides

European Commission Joint Research Centre, 27 May 2011 http://ihcp.jrc.ec.europa.eu


EU food safety agency to test aspartame

2011-06-01

After the publication of new scientific studies revealing the potential negative impact of aspartame on pregnant women and evidence linking the sweetener with an increased risk of cancer, the European Commission has requested the EU’s food safety watchdog (EFSA) to conduct a full re-evaluation of the substance by July 2012. Aspartame has already been re-assessed five times since it was authorised for use in the EU in 1994. The next review of the chemical sweetener was foreseen for 2020 as part of the systematic re-evaluation of all authorised food additives in the EU. However, following intense political pressure from members of the European Parliament, who were alarmed by new scientific studies showing its potential negative effects, the EU executive has requested the European Food Safety Authority (EFSA) to bring forward a full re-evaluation of the sweetener’s safety to 2012. Two studies of the possible health risks related to the consumption of artificial sweeteners were published last year. A carcinogenicity study in mice exposed to aspartame in feed, conducted by Italian oncologist Morando Soffritti, signalled an increased risk of liver and lung cancer in mice exposed to the chemical sweetener over the course of their lives. An epidemiological study involving 60,000 pregnant women, carried out by Icelandic researcher Thorhallur Halldorsson, demonstrated that there is a link between intakes of artificially sweetened soft drinks and increased incidences of premature childbirth. In a February 2011 statement, EFSA concluded that the two studies do not give any reason to reconsider previous safety assessments of aspartame or of other sweeteners currently authorised in the EU. Dutch MEP Kartika Liotard (European United Left/Nordic Green Left), who has called into question the safety of aspartame since 2005, welcomed news of the re-assessment. Her group considers it outrageous that so much political pressure was required before EFSA and the European Commission finally decided to move on the topic. “The Authority just ignored the findings of the investigations in February saying they were ‘unreliable’. That amounts to playing with public health. Even the smallest clue that aspartame could cause cancer or miscarriages should be a reason for an assessment to be seriously considered. Now, they have finally succumbed after years of pressure from the European Parliament. This indicates that EFSA and the Commission’s data on the safety of aspartame is not 100% certain,” said Liotard. Alliance of Liberals and Democrats for Europe (ALDE) group MEPs Corinne Lepage (France) and Antonyia Parvanova (Bulgaria) said that the Commission had apparently finally taken into account their repeated requests for a complete review of the aspartame safety profile, asking EFSA to conduct one before July 2012. “This is good news but in the meantime we repeat our call for public information on the uncertainties concerning health implications to be available, and for pregnant women to be informed about suspected risks for the foetus, as voted in the environment committee,” the ALDE MEPs said. “We should denounce how careless the EFSA and the Commission have been handling this case until now; recent exchanges of letter between NGOs and the EFSA seem to indicate that the EFSA never took the time to look at the original evaluation, and that data have even been lost!,” they added. EU food and drink industry confederation CIAA stressed earlier this spring in a public hearing on aspartame that the food and drink industry was committed to providing consumers with choice. Moreover, authorisation of the sweetener had enabled the EU food and drink industry to innovate, responding to consumer demands and increasing consumer choice, offering safe “energy reduced” or “without added sugar” food and drink products in addition to their traditional counterparts, the CIAA said. The confederation also noted that aspartame’s presence is labelled twice, if not three times, on all food and drink products in which it is used. “This provides consumers with the information necessary to make informed choices,” it said.

Euractiv, 31 May 2011 http://www.euractiv.com


Commission aims to slash plastic bag use

2011-06-01

The European Commission is considering a tax or a ban on plastic bags as it seeks the public’s views on how to reduce their use and fight pollution. On 18 May, the Commission called for suggestions on how to deal with the billions of bags used in the European Union each year, but which take hundreds of years to decompose. “Fifty years ago, the single-use plastic bag was almost unheard of. Now we use them for a few minutes and they pollute our environment for decades,” EU Environment Commissioner Janez Potocnik said in a statement. Each person in the 27-country European Union uses on average 500 plastic carrier bags per year – most of them just once. A total of 3.4 million tonnes of plastic bags, weighing the same as about two million cars, were produced in Europe in 2008. Several countries have already introduced bans on disposable plastic bags or struck agreements with retailers to phase them out. Most supermarkets now charge for their use. But there is no specific measure at EU level, the Commission points out, saying “effective action is needed”. Furthermore, the Commission is seeking the public’s views on how to boost biodegradability of packaging, with an upcoming review of the EU Packaging Directive. The review will also look at clearer labelling for biodegradable bags in order to help consumers make better choices. “Advertising a packaging product as biodegradable when in fact it will not biodegrade in natural conditions can be misleading, and contributes to the proliferation of litter,” the EU executive said. The Commission’s public consultation will close at the end of August.

Euractiv, 19 May 2011 http://www.euractiv.com

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