ASIA PACIFIC
~dLegislation
~tCost Recovery Impact Statement - CRIS
~w2010-06-25
On 23 June, NICNAS released the Cost Recovery Impact Statement (CRIS)
discussion paper. The purpose of this discussion document is to
present information for stakeholder consideration and to invite
feedback on issues to be included in the NICNAS CRIS. Feedback
received will be duly considered in the development of the CRIS. The
objectives of this consultation are to:
 Identify and understand any issues with the current cost
recovery framework;
 Obtain a clear understanding of how NICNAS activities have
changed since the last CRIS in 2004-05;
 Prioritise the major issues of stakeholder concern regarding
the efficiency and effectiveness of NICNAS operations; and
 Explore mechanisms to cost recover the accelerated assessment
of existing chemicals.
In addition, NICNAS will hold stakeholder workshops as follows:
Melbourne – Friday 16 July, 9 am-12 pm
Sydney – Monday 19 July, 9 am – 12 pm
A copy of the discussion paper can be found at:
http://www.nicnas.gov.au/Current_Issues/CRIS/CRIS%20discussion%20docu
ment%20-%20Final%2020100623.pdf
NICNAS, 23 June 2010
<ahref="http://www.nicnas.gov.au/">http://www.nicnas.gov.au/</a>
~dLegislation
~tFood standards updates
~w2010-06-25
FSANZ is considering replacing the current regulatory Nutrient
Reference Values (rNRVs) in the Australia New Zealand Food Standards
Code (the Code) with new ones. For almost 20 years the rNRVs in the
Code for vitamins and minerals have been based on Recommended Dietary
Intakes (RDIs) for Use in Australia that were created in 1991 and
were used in both Australia and New Zealand. In 2006, the National
Health and Medical Research Council (NHMRC) and the New Zealand
Ministry of Health (NZ MOH) released a new set of official NRVs for
Australia and New Zealand. NRVs indicate the daily amount of
nutrients required for good health, as well as a safe intake of
nutrients. The 2006 NRVs include measures of both nutrient adequacy
and safety. The 2006 NRVs introduced several significant changes to
the 1991 NRVs, then known as RDIs. In particular, they:
 expanded the range of nutrients assigned nutrient reference
values
 introduced new types of reference values, including for
macronutrients
 revised many of the 1991 recommended daily intakes (RDIs)
 modified the age ranges
 modified the units for folate
 revised the presentation of energy requirements
FSANZ is considering whether to revise the regulatory NRVs based on
the 2006 NRV measures of nutrient adequacy. To help in their
deliberations, a public consultation paper has been released seeking
comment from interested parties on the underlying principles,
relevant issues and potential approaches to revising the regulatory
NRVs in the Code. This consultation will inform any future action,
which may include the development of a proposal to amend the
regulatory NRVs in the Code. Comments will be received until 30 July
2010. For full details of the changes go to:
http://www.foodstandards.gov.au/foodstandards/changingthecode/documen
tsforpublicco868.cfm
Food Standards Winter Newsletter, June 2010
<a href="http:// www.foodstandards.gov.au">http://
www.foodstandards.gov.au</a>
~dLegislation
~tAmendments to the regulations
~w2010-06-25
As part of the regulatory reform program a number of amendments have
been made to the Therapeutic Goods Regulations 1990 and the
Therapeutic Goods (Medical Devices) Regulations 2002, both made under
the Therapeutic Goods Act 1989.
The principal amendments include:
 revise fees and charges
 implement the detail of the revised scheduling arrangements
 implement a new in-vitro diagnostic devices (IVD) framework
 improve the arrangements for therapeutic goods advisory
committees
 implement an infringement notices scheme
 make a number of important minor amendments including enabling
medical devices to be transferred to another person and
providing details for a low value, low volume exemption for
goods in the Register from the requirement to pay annual
charges
For full details of the new amendments go to:
http://www.tga.gov.au/regreform/
TGA, 23 June 2010
<a href="http://www.tga.gov.au/">http://www.tga.gov.au/</a>
~dLegislation
~tCancer cases on the rise, says health report
~w2010-06-25
According to a new major report, new cases of cancer are headed for a
10 per cent increase this year compared to 2006. The number of people
diagnosed with the disease in 2010 is predicted to rise to 115,000.
The report, Australia's Health 2010, will show the overall cancer
incidence rate increased 4 per cent in the decade to 2006. Cancer has
become the nation's leading disease, taking 19 per cent of the health
system's effort in treating diseases compared with 16 per cent for
cardiovascular disease. The number of deaths from cancer is expected
to top 43,700 in 2010. Lung cancer was by far the most common cause
of cancer death in 2007 and people living in remote and regional
areas were found to have higher disease risk factors. Lung cancer
killed 4715 men and 2911 women. In addition, the report finds
lifestyle risks contribute to more than 30 per cent of deaths,
disease and disability, and cites tobacco smoking as the single most
preventable cause of ill-health and death in Australia. The report by
the Australian Institute of Health and Welfare is a key statistical
tool used by the government to plan healthcare services. Health
Minister Nicola Roxon said that although survival rates had improved
significantly for many cancers in the past 20 years, "cancer is still
placing an intolerable burden on our community". Ms Roxon said the
Rudd government had planned substantial improvements to rural and
regional cancer facilities in a bid to close the gap in cancer
survival rates in remote areas.
The Australian, 23 June 2010
<a
href="http://www.theaustralian.com.au">http://www.theaustralian.com.a
u</a>
AMERICA
~dLegislation
~tEPA places four IRIS assessments on hold pending review
~w2010-06-25
The U.S. Environmental Protection Agency (EPA) recently announced
that it is holding four of its ongoing IRIS (Integrated Risk
Information System) assessments pending a review of some of the
underlying studies used in the assessments. EPA conducts IRIS
assessments to determine the impact of specific chemicals on human
health. These assessments are being conducted due to a report from
the National Toxicology Program (NTP) that outlines a recent review
of a research study completed by the Ramazzini Institute, a lab in
Italy that conducts animal testing to evaluate the potential cancercausing effects of chemicals. The report discusses findings from a
recent assessment by NTP pathologists of an animal study on methanol.
NTP’s report recommends that further pathology reviews be carried out
to resolve differences of opinion between NTP scientists and the
Ramazzini Institute in the diagnoses of certain cancers reported in
the study. Out of an abundance of caution and to ensure the agency’s
chemical assessments are grounded in the soundest possible science,
EPA undertook a thorough review of all ongoing and previous chemical
assessments to determine which, if any, relied substantially on
cancer testing from the Ramazzini Institute. EPA found six
assessments that significantly rely on data from Ramazzini cancer
studies:
Assessments currently in progress: EPA found four ongoing chemical
assessments – on methanol, MTBE, ETBE and acrylonitrile that rely
significantly on cancer data from the Ramazzini Institute. EPA has
placed those assessments on hold and will determine whether the
questions raised by NTP will require EPA to revise the assessments or
take additional action to verify the data used in these assessments.
EPA also postponed a 23 August meeting of the agency’s Science
Advisory Board, which had been previously scheduled to review the
draft methanol assessment.
Previously completed assessments: Out of more than 540 completed
assessments posted on the Integrated Risk Information System (IRIS),
EPA identified two – Vinyl Chloride and 1,1- Dichloroethylene – that
relied substantially on findings from Ramazzini Institute cancer
studies. EPA is reviewing these assessments as well to determine what
action is needed to assure their scientific integrity. EPA will
continue its review to determine if any other assessments are
significantly impacted.
Environmental Expert, 18 June 2010
<a href="http://www.environmentalexpert.com">http://www.environmental-expert.com</a>
~dLegislation
~tEPA Keeps Authority Over Greenhouse Emissions in Senate Vote
~w2010-06-25
An effort by Senator Lisa Murkowski (R–AK) to reject a finding by EPA
that carbon dioxide endangers human health has been defeated. Senate
Environment and Public Works Committee Chair Barbara Boxer (D–CA)
called the vote a "sign that we are ready to move forward" to
regulate greenhouse gas. But the margin of defeat raises serious
questions about President Barack Obama's ability to find the 60 votes
he would need to win approval of comprehensive greenhouse gas
regulations this year. "The bad news is that in a 60-vote Senate,
it's hard to imagine a climate bill, or even a mere energy bill that
does something about coal-fired plants, getting through," wrote
liberal columnist Ezra Klein of The Washington Post. Environmental
groups put a more positive spin on the close vote, claiming that it
shows momentum toward their goal. "A win is a win," said Conrad
Schneider, advocate for the Clean Air Task Force in Boston. "Since
the EPA regulatory process will go forward, that will both allow EPA
to continue to pursue regulations of greenhouse gases and pressure
the Senate to act." Indeed, several members who supported the
Murkowski measure said that they wanted to regulate greenhouse gases,
including both Republican senators from Maine. And Democrats in swing
states or states with big coal industries who voted to defeat
Murkowski include senators Robert Byrd (D–WV), Claire McCaskill (D–
MO), and Kent Conrad (D–ND). The 6-hour debate over the bill featured
Republicans arguing repeatedly about the need to prevent a "power
grab [by] Washington bureaucrats." In response, Democrats cited
physician groups and climate scientists that said greenhouse gases
are a threat to U.S. health and welfare. "If anyone thinks carbon
isn't dangerous," said Boxer, showing a picture of an oiled bird in
the Gulf of Mexico, "we see what carbon is doing in the gulf."
Senator Bernie Sanders (I–VT) cited climate statistics that he said
his opponents were ignoring, but Murkowski emphasized in her remarks
that the debate "is not about science."
Science Now, 10 June 2010
<a
href="http://sciencenow.sciencemag.org/">http://sciencenow.sciencemag
.org/</a>
~dLegislation
~tTCEQ Asks for Judicial Review of EPA's Rule Disapproval
~w2010-06-25
On 14 June, the Texas Commission on Environmental Quality (TCEQ)
filed an action petitioning the federal Court of Appeals for judicial
review of the U.S. Environmental Protection Agency's final
disapproval of the state agency's 1996 Qualified Facilities rule. The
TCEQ proposed revisions on 30 March to address EPA’s concerns about
the rules the federal agency proposed for disapproval in September
2009. However, EPA concurred in 1995 that the rule adequately
addressed federal permitting requirements, and the rule was formally
submitted to EPA in 1996. The Qualified Facilities rule applies to
facilities that request emissions authorisations that fall below
federal New Source Review (NSR) permit limits. The state law
authorises certain changes at facilities, provided any increase in
actual emissions is below emissions thresholds that require FNSR and
if the control technology at the facilities is no older than 10-yearold best available control technology. The TCEQ will continue to
defend its air permitting program while proactively working with EPA
to resolve its concerns to provide legal certainty to regulated
entities and the public.
Environmental Protection News, 16 June 2010
<a href="http://www.eponline.com">http://www.eponline.com</a>
~dLegislation
~tEPA to Seek Employee Participation in Chemical Safety Inspections
~w2010-06-25
The U.S. Environmental Protection Agency (EPA) has released interim
guidance that would provide greater transparency in the agency’s
chemical safety inspections process. Under the interim guidance, EPA
inspectors will offer employees and employee representatives the
opportunity to participate in chemical safety inspections. In
addition, EPA will request that state and local agencies adopt
similar procedures under the Risk Management Program. EPA believes
that close involvement of employees and employee representatives in
inspections is effective and better protects workers and the adjacent
communities. The interim guidance pertains to inspections conducted
by EPA under the agency’s Risk Management Program (RMP). Through this
program, EPA seeks to reduce the risks to surrounding communities
that arise from the management, use or storage of certain hazardous
chemicals. Owners and operators of covered facilities must develop a
risk management plan, which includes facility plans for the
prevention and response to chemical accidents. Under the Clean Air
Act, the Chemical Accident Prevention Provisions require facilities
that produce, handle, process, distribute, or store certain chemicals
to develop a Risk Management Program, prepare a risk management plan,
and submit the plan to EPA. EPA expects to issue final guidance on
participation of employees and employee representative in RMP
inspections later this year.
EPA, 22 June 2010
<a href="http://www.epa.gov">http://www.epa.gov</a>
~dLegislation
~tDraft Regulation for Safer Consumer Products
~w2010-06-25
The Green Chemistry Draft Regulation for Safer Consumer Products is
now available for review and comment. This draft regulation is built
on the foundation outlined in the previously released Conceptual
Flowchart and Outline for Draft Regulation. The draft regulation
specifies the processes for DTSC to scientifically and systematically
identify and prioritise chemicals and consumer products, for
manufacturers to conduct alternatives assessments, and for DTSC to
impose regulatory responses for alternatives selected by
manufacturers. The regulation reflects nearly 16 months of
collaboration with stakeholders, including the use of a “wiki” to
gather information electronically; numerous formal and informal
meetings and workshops; input from the Green Ribbon Science Panel;
feedback regarding a “straw” proposal released in late 2009; and the
Conceptual Flowchart and Draft Outline for Draft Regulation released
in the spring of 2010. Comments on the draft regulation are due by 15
July 2010. DTSC may revise the draft regulation based on comments
received and will release the revised draft following the 15 July
comment deadline. For full details of the draft regulation go to:
http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/u
pload/Safer-Product-Alternative-Regulations-6-23-10.pdf
California Department of Toxic Substance Control, 23 June 2010
<a href="http://www.dtsc.ca.gov">http://www.dtsc.ca.gov</a>
EUROPE
~dLegislation
~tExposure to BPA must be reduced, say scientists
~w2010-06-25
The European Food Safety Association (EFSA) have received a joint
letter from a group of 19 scientists and 41 environmental and health
groups, urging action to reduce the levels of bisphenol-A (BPA) in
groups at highest risks such as children. EFSA is due to issue a new
scientific opinion on the safety of BPA in food contact materials in
early July. The European Commission asked the scientific body to
assess the latest findings on the issue. EFSA previously declared BPA
safe. According to the letter's signatories, "only a tiny minority of
studies have articulated that BPA exposure is completely safe, and
many… have been criticised in academic commentaries…but it is these
few flawed studies that EFSA previously relied on [to deliver its
advice]. This seems to contradict preliminary findings published in
early June by France's national institute for health and medical
research (Inserm), which said it will take years before it can be
proven that BPA has long term impacts on human reproduction. The
letter refers to several new studies raising risks of exposure
relating to increased likelihood of, for example, developing diabetes
and breast cancer. "Any objective and comprehensive review of the
scientific literature will lead to the conclusion that action is
necessary to reduce the levels of BPA exposure," the authors say. An
increasing number of countries are taking action to address such
risks. In May, French MPs backed a temporary ban the use of BPA in
baby feeding bottles. In June, the German environment agency issued
guidance encouraging manufacturers, importers and users to use
alternative substances. In May, Swedish environment minister Andreas
Carlgren said that, if the EU did not quickly ban the hormone
disrupting substance bisphenol in baby bottles, Sweden would "precede
with a national prohibition". US and Canadian regulators have already
taken action to limit BPA exposure.
ENDS Europe Daily, 23 June 2010
<a
href="http://www.endseuropedaily.com">http://www.endseuropedaily.com<
/a>
~dLegislation
~tPhase-out of hazardous chemicals from Mediterranean
~w2010-06-25
Mediterranean countries have adopted new measures and mandatory
timelines to limit the impact of dangerous chemicals and pesticides
originating from industrial and agricultural activities on the marine
environment in the region. Mandatory measures to phase out hazardous
chemicals recently entered into force, under the Barcelona Convention
and the Mediterranean Action Plan. Targeted chemicals include those
found in waste water, a series of persistent organic pollutants used
as pesticides as well as DDT and its stockpiles. The implementation
of the Barcelona Convention started on 16th June, where verbal
commitments are framed by concrete deadlines for action, according to
Maria Luisa Silva, UNEP/MAP Officer-in-charge. 'This is a brand new
approach to tackling polluting chemicals, as the mandatory deadlines
and concrete measures will indeed accelerate the pace of effective
pollution reduction in the Mediterranean'. The implementation of the
chemicals phase-out in the 21 countries bordering the Mediterranean
basin and the European Union member states is expected to take place
between 2015 and 2019. This will include mandatory measures for the
treatment of waste water in coastal cities and urban centres before
its release into the sea. Urban waste water is the most serious
source of pollution in the Mediterranean. Francesco Saverio Civili,
MEDPOL Coordinator, said, 'We enter this new phase with renewed
enthusiasm. Additional measures can now be negotiated and
implemented, and we will continue to support the countries in the
implementation and further development of their regional plans’. The
plans were adopted at the 16th Meeting of the Contracting Parties to
the Barcelona Convention (Marrakesh, November 2009) and are a
powerful implementation tool of Article 15 of the Land Based Sources
(LBS) Protocol of the Convention, which states that countries should
adopt plans and programmes containing concrete measures and
timetables.
Environmental Expert, 25 June 2010
<a href="http://www.environmentalexpert.com">http://www.environmental-expert.com</a>
~dLegislation
~tMEPs demand EU authorisations for all biocides
~w2010-06-25
At the recent meeting of the European Parliament's environment
committee in Brussels, a vote to extend the European Commission's
proposed EU authorisation procedure to all biocidal products was
conducted, an idea initially proposed by German MEP Christa Klass.
The proposal was met with resistance from liberal and socialist MEPs
in April. However, MEPs adopted an amendment tabled by the industry
committee opening the scope. Companies would be able to choose
whether to be authorised by the EU or a member state. The open scope
has two exceptions. Substances that are carcinogenic, mutagenic and
reprotoxic (CMR) or persistent, bioaccumulative and toxic (PBT)
cannot be authorised at EU level. The same would apply for biocidial
products with available substitutes.The European Commission has
voiced concern that the European Chemicals Agency (ECHA) does not
have the time or resources to process too many EU authorisations. It
says these authorisations should only apply to low-risk biocides and
products based on new active ingredients, with all others still given
by member states. These concerns will only be heightened following
the committee's vote to lower ECHA's processing time from nine months
to three, and to abolish annual fees. In addition, MEPs said the
combined effects of different biocides should be taken into account
when authorising biocidal products, and that nanomaterials must be
assessed separately. Environment and health group HEAL welcomed the
committee's inclusion of chemicals' combined effects in the risk
assessment of biocides. "This move has come in recognition of growing
concern with the single substance approach taken in EU chemicals risk
assessment," a spokesperson said. According to Christa Klass's
office, some legal issues still need to be worked out before the text
adopted by the environment committee can be published. Some of the
amendments adopted by MEPs appear to be contradictory to each other.
The full parliament will vote on biocide proposals at its plenary
session in September. Member states have held off any decision on
biocides until Belgium takes over the presidency of the EU.
Negotiations between the parliament and the council will likely not
start until after the full plenary vote, according to a parliament
source.
ENDS Europe Daily, 22 June 2010
<a
href="http://www.endseuropedaily.com">http://www.endseuropedaily.com<
/a>
~dLegislation
~tEuropean Commission references study on GHS indicators
~w2010-06-25
The European Commission has referenced a study on suitable indicators
that can be used to measure progress in implementing the Globally
Harmonised System (GHS) of Classification and Labelling of Chemicals
at country level. The study lead by Unitar and published in the
Journal of Environmental Management covers indicators for policies
and actions. For full details go to:
http://ec.europa.eu/environment/integration/research/newsalert/pdf/20
0na5.pdf
Chemical Watch, 18 June 2010
<a
href="http://chemicalwatch.com/news">http://chemicalwatch.com/news</a
>
INTERNATIONAL
~dLegislation
~t‘Good talks’ provide springboard for mercury deal
~w2010-06-25
Global mercury talks in Stockholm ended with all 132 participating
countries, including the US and China, taking "a positive stance" to
the target of a binding global agreement on mercury by 2013, the
Nordic Council of Ministers reports. Internal EU wrangling over
whether the European Commission should be able to represent all
member states at the talks dominated conference preparations. But the
power struggle "failed to have the negative effect on the meeting
that many had feared", the council said in a statement. NGO coalition
the Zero Mercury Working Group said the discussions would provide "a
strong basis for developing the text of the treaty", starting at the
next meeting in Chiba, Japan, in January. The group "applauded" calls
by the World Health Organization for a ban on skin-lightening
cosmetics containing mercury and a "phase-down" of dental amalgam
ENDS Europe Daily, 14 June 2010
<a
href="http://www.endseuropedaily.com">http://www.endseuropedaily.com<
/a>