ASIA PACIFIC
~dLegislation
~tPublic information process enhanced
~w2011-03-09
The Australian Pesticides and Veterinary Medicines Authority (APVMA) have made it easier for members of the public to access information regarding the regulation of pesticides and veterinary medicines.Three main initiatives have now been completed. Enhancements to the APVMA website have improved the quality and accessibility of regulatory information. These enhancements are ongoing in response to user feedback. In addition, changes have been made to the Contact Us page of the website to make it easier for stakeholders to direct their questions to the appropriate area of the APVMA.Finally, the electronic Ask a Question system on the website has been replaced with a simpler and more responsive process. People who need information can now simply email the Public Affairs team using dress for a quick and effective response.The Ask a Question facility remains on the APVMA website but will be removed at the end of March 2011.
APVMA, 3 March 2011
<a href="
~dLegislation
~tNotice of Publication of the Summary Report of Existing Chemical Secondary Notification N-(N-BUTYL) Thiophoshoric Triamide
~w2011-03-09
On 1 March, The National Industrial Chemicals Assessment Scheme (NICNAS) announced that the industrial chemical, N-(n-butyl) thiophosphoric triamide (NBPT), has been assessed as an existing chemical secondary notification under the Commonwealth Industrial Chemicals (Notification and Assessment) Act, 1989 (the Act), as amended. An assessment report (NA/467S) has now been published under section 60F of the Act and is available from the NICNAS website at:
The summary report has been prepared in accordance with subsection 60F(4) of the Act. The publication of this report revokes the declaration of NBPT as a chemical for secondary notification under section 62 of the Act.
NICNAS Chemical Gazette, 1 March 2011
<ahref="
~dLegislation
~tSurface inversions for Australian agricultural regions
~w2011-03-09
To increase the awareness and understanding of inversion conditions when spraying agricultural chemical products, the APVMA has recently published information to help chemical users identify and manage these conditions. The information discusses how users can recognise temperature inversions and anticipate when they may form. In addition, the document outlines the hazards associated with surface inversions including radiation inversions and their causes. It provides details on the transport of airborne pesticides, explains the typical lifecycle of radiation inversions and variations to the lifecycle. Finally the document discusses what chemical applicators should do to anticipate and recognise radiation inversions. A copy of the information sheet can be found at:
APVMA, 4 March 2011
<a href="
~dLegislation
~tERMA releases decision on trichlorfon
~w2011-03-09
new Zealand’s Environmental Risk Management Authority has recently released its decision on the review of the organophosphate insecticide trichlorfon. Trichlorfon is used to control a range of insects in a variety of horticultural and agricultural crops. It is also used as a veterinary medicine. The Authority has decided t to phase out approvals for the further importation or manufacture of trichlorfon for plant protection purposes. In making its decision, the Authority said the use of trichlorfon for plant protection purposes posed risks to the environment which could not be safely managed. A three-month phase-out period has been set. From 1 June 2011, trichlorfon for use on plants may no longer be imported into, or manufactured in New Zealand, and existing stocks must be used or disposed of.The Authority has approved the continued use of trichlorfon as a veterinary medicine, with stricter controls.It said the addition of stricter controls on trichlorfon’s use as a veterinary medicine would safely manage any potential risks. The new controls come into effect on 1 June 2011. The reassessment of trichlorfon is part of a wider review of organophosphates used in New Zealand and internationally.
ERMA, 23 February 2011
<a href="
~dLegislation
~tKorean REACH-Like Proposal Released for Public Comment
~w2011-03-09
On 25 February 2011, the Korean Ministry of the Environment (MOE) released a draft of the "Act on the Registration and Evaluation of Chemicals", a Korean version of REACH, for a 60-day comment period. This new Korean proposal will have significant implication for companies that do business in Korea and may have spill over effects in other Asian trading partners as they organise/reorganise their chemical legislation.The Draft Act would wholly amend the current Korean Toxic Chemicals Control Act (TCCA). Specifically, it would introduce many of the same legal concepts as REACH into Korean law, (i.e. pre-registration, registration, evaluation, authorisation and restriction). However, in practice, these legal concepts will apply very differently under the Draft Act than as compared to REACH, in particular with respect to the registration of substances. Most notably, registration will apply to new substances and to priority existing chemical substances selected on the basis of potential risk. The scope of the Draft Act excludes cosmetic ingredients that are approved for use and fertilisers as well as some of the other classes of substances exempted under REACH. There are additional exemptions from registration for which the potential registrant must seek confirmation of exempt status, risk assessment information is automatically required as part of the registration dossier at the 100 tonnes level as opposed to the 10 tonnes level under REACH. There is a maximum 8-year transitional period for pre-registered priority existing chemicals. The MOE will prepare a hazard assessment for all registered substances and will prepare risk assessments to identify chemicals for authorisation, restriction, or prohibition as appropriate. There is an obligation to submit data jointly to avoid unnecessary animal testing and to provide proof of the right to use the data where appropriate, and there is a provision for a representative to be appointed by the foreign exporter. There are many favourable aspects of the Draft Act, but many uncertainties, and potentially unfavourable aspects:
-Specifically, the criteria for deciding whether substances are of priority for registration are unclear.
-The exemptions are far fewer than they should be, given the substantial burdens.
- MOE is given unbridled discretion to decide the scope of the exemptions.
-There are significant issues surrounding provisions for maintaining the confidentiality of data.
- There is no provision for utilising the information already assembled under REACH in order to avoid duplication of effort.
-The standards by which MOE will decide whether a substance is of concern are not specified.
-There are many other uncertainties that should be addressed during the legislative process.
-The deadlines for Registration are too compressed.
-The minimum tonnage band that triggers the registration obligation is too low.
-No procedures are set out to challenge MOE's decisions.
Keller & Heckman, 1 March 2011
<a href="
AMERICA
~dLegislation
~tFDA Intends to Remove Unapproved Drugs from Market
~w2011-03-09
The U.S Food and Drug Administration (FDA) recently announced that the agency intends to remove certain unapproved prescription medicines intended to relieve cough, cold, and allergy symptoms from the U.S. market.These products have not been evaluated by FDA to assure that they are safe, effective, and of good quality. Therefore, these products may pose unnecessary risk to consumers, especially when there are other products available for treatment of cough, cold, and allergy symptoms, including FDA-approved prescription drugs or over-the-counter drugs that follow appropriate FDA standards.FDA officials say they have numerous concerns about these products: some may have potentially risky combinations of ingredients, while others—marketed as “timed-release”—may release active ingredients too slowly, too quickly, or inconsistently. In addition, FDA has received reports that some of the products have names that look or sound similar to other products—a problem that could contribute to medication errors.FDA health experts are also concerned that some of the products are inappropriately labelled for use by infants and young children. Many of the unapproved drug products covered by the recent announcement contain the same ingredients as the over-the-counter cough and cold products that were the subject of a 2008 FDA public health advisory.That 2008 advisory said non-prescription cough and cold products should not be used for infants and children under 2 years of age because of serious and potentially life-threatening side effects. Many manufacturers voluntarily withdrew products labelled for children under 2 years old, and some products were relabelled to state that they were not for use by children under 4 years old.“Removing these unapproved products from the market will reduce potential risks to consumers from products that have never been evaluated by the FDA for safety, effectiveness, and quality,” says Deborah Autor, compliance director at FDA’s Centre for Drug Evaluation and Research. According to the FDA, most manufacturers affected by the recent action must stop making the products within 90 days and stop shipping them within 180 days. (Some manufacturers may have to stop making and shipping their products immediately.)
Autor says taking them off the market shouldn’t create problems for consumers because there are many other products—both prescription and over-the-counter—available for treatment of cough, cold, and allergy symptoms that meet FDA standards.Some of the prescription medicines being removed have been marketed for many years. Over the past century, the laws outlining the requirements for drug approval have changed. First, drug regulation focused on adulteration and misbranding, but did not require that new drug products be approved prior to being marketed. Then, laws on drug regulation changed to include drug safety as a requirement for approval.Currently, the law requires that new drugs be shown to be safe, effective, of good manufacturing quality, and not misbranded prior to being approved by FDA for marketing in the United States. In part as a result of these changes in the law, many of the products that are the focus of this action have been marketed without being approved under the current legal requirements.If you are taking a prescription medicine for cough, cold, or allergy symptoms and you want to know if it is an approved drug, use one of the FDA resources listed below. (These resources do not include many over-the-counter drugs because many of these drugs do not require FDA approval to be legally marketed.)
- Drugs@FDA (contains most FDA-approved drug products):
If a product is not included here, the search results will say “Your search term did not return any results.” - The Orange Book List of Approved Drug Products:
If a product is not FDA approved, the search results will say, "No matching records found." - The National Drug Code (NDC) Directory of prescription drugs and insulin products:
Search results include a column marked "Appl No." FDA-approved products will have an associated NDA (new drug application) or ANDA (abbreviated new drug application) number in this column.
If you are taking one of the unapproved prescription medications that are affected by this FDA action, discuss alternatives with your health care provider.
FDA, 2 March 2011
<a href="
~dLegislation
~tEPA approves California’s efforts to become nation’s first PERC-free dry cleaning state/ Hazardous dry cleaning chemical to be removed by 2023
~w2011-03-09
The U.S. Environmental Protection Agency has approved California’s regulations banning the use of the toxic air contaminant perchloroethylene (PERC) from the state’s dry cleaning operations by 2023. This action means that the current federal regulations will be replaced with California’s more stringent approach, which now can be enforced by the federal EPA and citizens of California. PERC, a possible human carcinogen, is a man-made liquid solvent often used in the dry cleaning industry, in textile mill operations, by chlorofluorocarbon producers, for vapour degreasing and in metal cleaning operations. The dry cleaning industry is a leading user of PERC in the U.S. “We applaud California’s efforts to rid its dry cleaning industry of this dangerous toxin,” said Jared Blumenfeld, the EPA’s Regional Administrator for the Pacific Southwest. “The state’s approach gives consumers healthier dry cleaning alternatives.” According to California’s Air Resources Board, the estimated number of PERC-using machines has been steadily dropping from 4670 machines in 2003 to 2000 machines in 2009. Meanwhile, the estimated number of wet cleaning and CO2 machines – which use less toxic cleaning methods – has almost tripled from 90 machines in 2003 to 253 machines in 2009. EPA’s Toxic Reporting Inventory database reports that more than 107,043 pounds of PERC were released to the environment in California in 2009, mostly through air emissions. Exposure to PERC can occur in the workplace or in the environment following releases to air, water, land, or groundwater. Exposure can also occur when people use products containing PERC, spend time in dry cleaning facilities that use PERC, live next to dry cleaning facilities, or bring dry cleaned garments into their homes. Once in the body, PERC can remain stored in fat tissue. In addition to being a possible human carcinogen, exposure to PERC is also associated with chronic, non-cancer health effects, including liver and kidney damage in rodents, and neurological effects in humans. California’s Airborne Toxic Control Measure for dry cleaning operations implements a ban on the use of PERC in dry cleaning operations in California. All remaining PERC dry cleaning machines must be removed from service by 1 January 2023. The California Air Resources Board identified PERC as a toxic air contaminant in 1991, and adopted the current Airborne Toxic Control Measure regulating PERC dry cleaning operations in 2007.
Environmental Protection Agency, 7 March 2011
<a href="
~dLegislation
~tChecking For Contaminants
~w2011-03-09
Under a new Environmental Protection Agency proposal, utilities will have to test drinking water for the presence of 28 chemicals, including several hormones and perfluorinated compounds.None of the substances in the proposal is regulated under the Safe Drinking Water Act. But that law requires EPA every five years to identify up to 30 unregulated contaminants for possible monitoring.Twenty-eight substances are proposed for monitoring. They include compounds important to chemical manufacturing, such as the feedstock 1,1-dichloroethane and 1,3-butadiene, which use in making synthetic rubber and plastics. Other compounds in the proposal are: sex hormones, including estradiol; the solvent 1,4-dioxane; the pesticide methyl bromide; and six perflurorinated compounds, including perfluorooctanoic acid. Four metals – cobalt, molybdenum, strontium, and vanadium – are also listed in EPA's proposal.In addition, EPA also included norovirus and enterovirus for possible monitoring, bringing the total number of contaminants listed in the proposal to 30. The 28 substances and two viruses were drawn from an initial list of about 150 chemical and microbiological contaminants, EPA says."Learning more about the prevalence of these contaminants will allow EPA to better protect people's health," says Nancy Stoner, acting assistant administrator for EPA's Office of Water.In the proposal, the agency notes that it does not include hexavalent chromium on its new list. The compound gained notoriety with the release in 2000 of the hit film "Erin Brockovich"--the real life story of a young legal researcher who battled Pacific Gas & Electric in California, for polluting drinking water with the carcinogenic substance. EPA Administrator Lisa P. Jackson told Congress earlier this year that the agency is likely to regulate the substance in drinking water."EPA is aware of potential concerns about Cr6+ occurrence in public water supplies," the proposal says, but the agency had already hit the maximum number of contaminants under the law. Instead, the agency is seeking comments from the public on whether it should require utilities to monitor drinking water for CR6+. Furthermore, the agency asked any proponents of this idea to suggest which of the 30 contaminants in the proposal should come off the list to make room for CR6+.The Environmental Working Group (EWG), an activist group that has sought regulation of perfluorooctanoic acid in drinking water, praises EPA for including perfluorinated chemicals in the proposal.EWG also says that because EPA is seeking voluntary monitoring of Cr6+ by utilities, it makes sense that the agency did not include the metal among the contaminants in proposed regulation. If Cr6+ is included in the final version of the rule, data collection will not start until 2012. EWG says it "greatly hopes that the chromium-6 monitoring will take place much sooner than that."
More information on the proposal is available at water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/ucmr3/index.cfm.
Chemical & Engineering News, 4 March 2011