Tpublic Discussion Paper Released on Proposed Regulatory Reform of Industrial Nanomaterials

ASIA PACIFIC

~dLegislation

~tPublic Discussion Paper Released on Proposed Regulatory Reform of Industrial Nanomaterials

~w2009-11-13

Recently, Mark Butler, the Parliamentary Secretary for Health, announced the release of a public discussion paper inviting consultations on a Rudd Government proposal to strengthen regulation of industrial nanomaterials use in Australia.The discussion paper proposes specific regulatory measures for the emerging field of nanotechnology in industrial chemicals. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) developed the proposal in conjunction with its Nanotechnology Advisory Group, which comprises representatives from industry, the community and research sectors. The proposal outlines the six trigger areas for regulatory reform identified by the independent Monash Report: Review of the Possible Impacts of Nanotechnology on Australia’s Regulatory. The new paper review major regulatory reforms including: refinement of pre-market assessment categories for nanoforms of new chemicals, particularly where human health or environmental exposure can reasonably be anticipated; and a mandatory notification and assessment program for nanoforms of existing chemicals. NICNAS will be working with comparable overseas regulatory authorities that are also actively considering similar measures. The Rudd Government say that they are committed to the responsible development of nanotechnology that captures its benefits while addressing any potential risks. The findings from the new discussion paper will provide valuable input for regulatory policy on nanotechnology use in the industrial sector.The discussion paper contains a questionnaire and survey to encourage written submissions and, depending on interest, public consultations in major cities will commence from 16 November. A copy of the discussion paper can be found at:
Department of Health & Aging, 9 November 2009

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~dGossip

~tDecisions regarding requests to vary the draft priority existing chemicals report for sodium cyanide

~w2009-11-13

The National Notification and Assessment Scheme (NICNAS)have announced that in accordance with section 60E(6) of the Industrial Chemicals (Notification and Assessment) Act 1989, notice the Director has made a decision regarding each request to vary the draft Priority Existing Chemical report on sodium cyanide. For full details of the decision go to:

NICNAS Chemical Gazette, November 2009

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~dLegislation

~tFive-year phase out for AZM insecticide

~w2009-11-13

New Zealand’s Environmental Risk Management Authority (ERMA) has announced a decision that will see the insecticide azinphos methyl phased out over five years. AZM is a broad-spectrum organophosphate used in New Zealand to control insects on crops including potatoes, summerfruit and strawberries. Its use has been withdrawn in the European Union and there are moves to phase it out in Canada and the United States. In addition, Australia is currently reassessment its use. In its decision, the Authority revoked three approvals to import, manufacture or use AZM formulations not currently in use New Zealand. The one formulation that is in use in New Zealand has been approved for use on potatoes, summerfruit and strawberries until December 2014, subject to additional controls. The five-year phase-out recognises the need for alternatives to be developed to meet the needs of growers and is based, in part, on submissions providing information on the length of time needed to develop and trial potential alternative products.Additional controls have been placed on the use of AZM in the phase-out period to reduce its risks to people and the environment.These include a ban on domestic use or aerial application of the substance, relabelling, creating buffer zones to protect bystanders and the environment, a requirement that protective equipment be worn by workers re-entering an area that has been sprayed, and limiting the number of applications per year. ERMA New Zealand’s Hazardous Substances General Manager Andrea Eng says the submissions provided valuable information for the decision-making committee. “The committee recognised there are some uses of AZM for which there are no registered alternatives and in these cases the risks and benefits are finely balanced,” Ms Eng says. “A five-year phase-out will allow time for alternatives to be trialled and registered.” For full details of the decision go to:

ERMA, 6 November 2009

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~dLegislation

~tOutlook Taiwan: returning from the slump with amended substance legislation

~w2009-11-13

Taiwan’s electronics industry faces new legislation in regards to the management of toxic substances. Taiwan’s Toxic Chemical Substances Control Act, which regulates all handling of hazardous substances, has been updated. There are new restrictions in the use of substances like mercury, asbestos and dioxane. In addition, bisphenol A has been added to the restrictions list. It is used primarily to make plastics and has long been used in baby and water bottles, sports equipment, CDs and DVDs and household electronics. The substance has endocrine disruptive properties, meaning it can copy the human body’s hormones, causing negative health effects.

Environmental Expert, 22 October 2009

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AMERICA

~dLegislation

~tEPA releases guide to help scientists understand children’s exposure to pollutants

~w2009-11-13

The U.S. Environmental Protection Agency has released a user-friendly document to help risk assessors understand how children are exposed to pollution. The document, titled “Highlights of the Child-Specific Exposure Factors Handbook,” serves as a quick-reference guide to the more comprehensive “Child-Specific Exposure Factors Handbook,” published by EPA in 2008. It will serve as an additional resource for those who work on children’s health issues, which the agency has been highlighting during Children’s Health Month. The reference material, developed by EPA, provides important information necessary for answering questions regarding exposure through drinking water, breathing, and eating foods, such as:

• How much exposure to environmental pollutants might children get if they live or play near contaminated sites?
• How much dirt from a child’s hands might s/he inadvertently eat?
• How much of a child’s exposure to various pollutants might come from skin contact?
• Which age groups (childhood life stages) may inhale or ingest the most and thus may be at higher risks?

U.S Environmental Protection Agency, 28 October 2009

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~dLegislation

~tAmendment dangerous goods safety marks

~w2009-11-13

A new proposal addresses the amendment of some of the dangerous goods safety mark issues encountered since the introduction of Amendment 6. The new amendment has been published on Transport Canada’s (TC) website for public comment. The proposed regulatory changes including:

• Section 1.39 will now include Part 4 Dangerous Goods Safety Marks as a section that does not apply for a shipment of infectious material, Category B. In other words, the Class 6.2 hazard label is not required.
• Section 4.9 goes back to wording prior to Amendment 6 with some additional text to clarify requirements. This section allowed placards to be displayed until all dangerous goods had been removed from the truck.
• Section 4.15 will be deleted and replaced with a revised section:Editorial changes to 4.15(1) – “… a placard or a placard and UN number ..”;
• The table in 4.15(1) has been re-structured – items 1 & 2 deal with dangerous goods that do not meet the requirement for an ERAP; and items 3, 4 & 5 do deal with ERAPs; the intent is to clarify and provide a logical flow of information;
• Transport Canada is proposing to delete the 4,000 kg rule as it does not provide harmonization with the US;
• The references to the DANGER placard in the table are removed and replaced with specific paragraphs in Part 4;
• Section 4.15(2) is to be deleted and replaced by the current 4.15(3);
• A new section 4.15(3) states that if there is a bulk shipment on a flatbed, the flatbed does not need to be placarded;
• A new section, 4.15.1, deals with subsidiary placards which is the current section 4.15(4);

• A new section 4.16.1 deals with the DANGER placard and there are some significant rule changes:
• The truck must contain dangerous goods in 2 or more different primary classes, and
• The dangerous goods must be in 2 or more small packages.
• The DANGER placard cannot be used:

* When a consignor offers one class of dangerous goods with a gross mass > 1,000 kg;

* When UN numbers or a subsidiary placard are required;

* For dangerous goods with emergency or control temperatures are required;

* Class 1 Explosives;

* Class 2.3 Toxic Gases;

* Class 4.3 Dangerous when wet;

* Class 5.2 Organic peroxides;

* Class 6.1 Toxic substances with PG I; or

* Class 7 Radioactive materials.

• A new section 4.16.2 500 kg Placarding Exemption means that the placarding rules are now permissive, in other words, a placard or a placard and UN number may be displayed even if the gross mass is ≤ 500 kg.
• Editorial changes to section 4.18(5) regarding UN1005 anhydrous ammonia, namely the date is removed and a requirement for the UN number inserted
• Section 4.21 Fumigation Sign has text removed to put this into line with the UN, IMDG Code and 49 CFR; the words “… and the fumigant is the only dangerous goods in transport in the large means of containment…” are deleted – if the fumigant is dangerous goods, then the fumigation sign must be displayed, regardless of what is in the container.
• Section 4.22(1) now reads that the Category B label is used in place of the Class 6.2 label
• The appendix to part 4 for the UN1005 anhydrous ammonia mark will now read “Placard for ..” rather than “Label and placard for …”In the appendix to part 4, the word “black” is deleted for the Category B mark; this will harmonise TDG with the UN and ICAO Technical Instructions.

Environmental Expert, October 2009
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~dLegislation

~tEPA to Revoke Rules Allowing Carbofuran Pesticide

~w2009-11-13

The Environmental Protection Agency is proceeding with the implementationof the agency's May 2009 final rule revoking tolerances, or residue limits, for the pesticide carbofuran. EPA continues to find that dietary exposures to carbofuran from all sources combined are not safe."The evidence is clear that carbofuran does not meet today's rigorous food-safety standards," said Steve Owens, assistant administrator for EPA's Office of Prevention, Pesticides and Toxic Substances. "EPA has carefully evaluated the scientific issues and has provided more than 500 days of public comment on this decision. It is now important to move forward with the needed public health protections, especially for children." Short-term health effects include headache, sweating, nausea, diarrhoea, chest pains, blurred vision, anxiety, and general muscular weakness.EPA encourages growers to switch from carbofuran to safer pesticides or other environmentally preferable pest control strategies. Since the tolerances are being revoked, EPA reminds growers that carbofuran should not be applied to any food crops after 31 December 2009. Use of carbofuran after this date could result in adulterated food products, which would be subject to enforcement by the FDA.During the objection period, the chemical company FMC Corporation, which manufactures carbofuran, and three grower associations submitted objections to EPA's tolerance revocations and requested an administrative hearing. EPA has concluded that the regulatory standard for holding an evidentiary hearing has not been met. EPA's explanation about why a hearing is not warranted, and the reasons for denying the objections are available on the web and will be published soon in a Federal Register notice. As part of the administrative process, FMC may appeal the revocation of the carbofuran tolerances to a federal circuit court of appeals.EPA's May 2009 action to revoke carbofuran tolerances was the result of a regulatory process that began back in 2006 when the agency published its risk assessments for carbofuran and determined, in August 2006, that no uses were eligible for re-registration. While FMC has voluntarily cancelled 22 carbofuran uses, the elimination of these uses was not sufficient to allow the agency to make a finding that combined dietary exposures to carbofuran from food and water are safe. The process to cancel the remaining carbofuran registrations is under way and will address unacceptable risks to farmworkers during pesticide application and to birds in and around treated fields. Further details on the new rules can be found at:

Envirnonmental Protection News, 3 October 2009

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~dGossip

~tVote brings US closer to reducing mercury pollution

~w2009-11-13

recently, the members of the U.S. House Energy and Commerce Committee voted to approve H.R. 2190 and move it out of committee. The bill would require chlor-alkali plants to end their use of mercury-based technology in chlorine and caustic soda production. The decision has been welcomed by Oceana,an international ocean conservation group, who for almost five years, have been working to persuade nine companies to switch from mercury-based technology to cleaner alternatives. Only threeU.S. companies have resisted. Ashta Chemicals (plant in OH), Olin Corporation (plants in TN and GA) and PPG Industries (plant in WV) have refused to switch to cleaner, mercury-free technology, despite the fact that doing so could make chlorine production more efficient, increase profitability and save U.S. jobs.Rep. Jan Schakowsky (D-IL), sponsor of H.R. 2190, worked tirelessly to build consensus among her colleagues for legislation that will ensure the protection of many Americans from mercury exposure.'Oceana is encouraged that Congress is one step closer to ending this major, unnecessary source of mercury contamination. Environmental Expert, 29 October 2009

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EUROPE

~dLegislation

~tMEPs split over EU biocide law revision

~w2009-11-13

The European Parliament’s Environment Committee is divided over plans to revise EU rules on biocidal products, following a first debate of the proposals recently. The Parliament's centre-right rapporteur Christa Klass criticised the European Commission's proposals for not going far enough to reduce the cost of biocide authorisations for industry. "I can see massive costs coming out of this proposal," Ms Klass said during the debate. The rapporteur asked why the Commission had only proposed a new EU-wide authorisation system for two types of products: low-risk biocides and products based on new active ingredients.According to the commission, products that do not fall in these two categories should continue to be authorised at national level, with strengthened rules on mutual recognition by other member states. "We need harmonisation for the internal market," argued Ms Klass. However, Dan Jørgensen, Danish centre-left MEP, said there was too much focus on reducing costs for industry at the expense of environmental and health protection. Mr Jørgensen predicted that the parliament's discussions on biocides would closely mirror its lively debates on a new EU authorisation procedure for pesticides in 2007.

ENDS Europe Daily, 6 November 2009

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~dLegislation

~tNo concern over fluorinated chemical levels in food - FSA

~w2009-11-13

According to the UK Food Standards Agency (FSA),there are no human health concerns regardingthe current dietary exposure to a range of fluorinated chemicals, such as PFOS and PFOA.The food safety watchdog came to its conclusion following testing on a range of retail foods for fluorinated substances - including perfluorooctane sulphonate (PFOS) and perfluorooctanoic acid (PFOA). The test results demonstrated that average adult dietary intake of the chemicals in 2007 fell well below tolerable daily intake levels set by the European Union, said the FSA. The agency said that during the research, it analysed the levels of PFOA, PFOS and related fluorinated chemicals in retail samples of fish, offal, meat, eggs, milk, dairy products, bread, cereals, popcorn, vegetables and jams. It found that almost three quarters of the foods contained no traces of any of the chemicals. All meat samples, with the exception of offal, were free from the substances, FSA scientists confirmed. The chemical that was detected most often and at the highest levels was PFOS – particularly in fish, liver and kidney samples. The two highest concentrations of PFOS were in whitebait and smoked eel. However, the chemical was absent from all samples of meat, potatoes, potato products, popcorn or other cereals, vegetable oils or fish oil dietary supplements. PFOS has recently been designated as a Persistent Organic Pollutant under the Stockholm Convention. This means that its use must be phased out eventually but that some uses are allowed to remain until alternative products are available. Perfluorooctane sulphonamide (PFOSA) was the next most frequently detected chemical, but only in fish and shellfish. The highest concentrations were found in two whitebait samples.

Low concentrations of PFOA were detected in only one sample of whitebait, six of crab and three of liver. PFOS and PFOA tend to bind to certain proteins rather than to bioconcentrate in fat, but they have some potential to bioaccumulate in the food chain. Accordingly, they are more likely to be found in the blood and liver rather than the fatty components of foods, said the FSA. Based on the results of the study, the FSA estimated the average adult dietary intakes from the diet in 2007 were 0.01 microgram/kg bodyweight/day for PFOS and 0.01 microgram/kg bodyweight/day for PFOA. The corresponding high level adult dietary intakes were 0.02 and 0.02 microgram/kg, said the body. According to the FSA, “The survey results do not raise any toxicological concerns. These are well below the Tolerable Daily Intakes (TDIs) recently set by the European Food Safety Authority of 0.15 and 1.5 microgram/kg bodyweight/day for PFOS and PFOA respectively.” The survey had been carried out to investigate which foodstuffs contain these chemicals, and update previous estimates of dietary intakes of the substances by UK consumers. The research could also be used to provide data for use in any future EU negotiations on the issue