ACTRA

Australasian College of Toxicology and

Risk Assessment

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August 2009 E-Newsletter

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Member news…

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Editor’s Note

ACTRA welcomes comments on any aspect of the e-newsletter. Please feel free to share suggestions or news, write letters to the editor or comment on articles presented. Your feedback is important to us!

Positions Vacant – Feel free to advertise positions in this newsletter. The dates for publication follow.

This is your newsletter!!

Please send contributions and Calendar notices to the Secretariat actra@meetingsfirst.com.au or editor jfrangos@bigpond.com

Submission deadlines

Issue 4: 30^th October

Submission rules

Publication of any material submitted to the ACTRA Newsletter will be the sole discretion of ACTRA. ACTRA reserves the right to make amendments to the submission prior to publication, or to refuse publication.

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President’s Report

Welcome to the third ACTRA newsletter for 2009. Thanks are due once again to the ACTRA Secretary John Frangos and the Meetings First Secretariat for putting together an interesting compilation of news and information about forthcoming events.

This Newsletter includes details of some forthcoming events, which you should note in your diaries.

AGM (26 September 2009)

Normally the AGM is held towards the end of the year, but it is being held a little earlier this year to facilitate attendance by those members also attending the asbestos workshop in Adelaide. The AGM will be convened on the Saturday evening at my home, in Adelaide, and will be followed by a simple dinner for those attending in person. For members unable to attend in person, arrangements will be made to join the AGM by teleconference. Formal papers for the AGM will be circulated shortly by the ACTRA Secretariat. Members are urged to consider nominating for one of the positions on the Management Committee, for which there will be a formal election process.

Asbestos Workshop (27 September 2009)

The asbestos workshop on 27 September 2009 is being held in Adelaide as one of the CE sessions associated with the CRC-CARE organised CleanUp09 conference.

ACTRA Annual Scientific Meeting (4 December 2009)

The ASM is being organised in Canberra in the margins of the annual conference of the Australian Institute of Occupational Hygienists. Members should consult the AIOH program (http://www.aioh.org.au/conference/2009/index.html) because there will be a number of topics which should be of interest to ACTRA members. The ACTRA ASM will again offer an opportunity for ACTRA members to submit abstracts and make presentations of research and other topics of interest in health risk assessment. The theme for the plenary session will be epigenetic mechanisms in toxicology – implications for risk assessment. We are currently negotiating for a prominent international scientist to present on this topic.

ACTRA Register of toxicologists and risk assessment professionals

As previewed in the June 2009 e-Newsletter, the ACTRA program to develop a Register of Toxicologists and Risk Assessors is moving forward. I understand that the Secretariat has already been receiving expressions of interest in this program from members. The Registration Tribunal is currently being assembled with a number of distinguished international and local toxicologists agreeing to participate. The information and forms needed to make an application are expected to be available soon on the ACTRA website.

Listing on the Register will be restricted to ACTRA members who satisfy the Registration Tribunal of their credentials and its main purpose is to provide information on the professional standing of those ACTRA members who choose to seek registration. As such it will hopefully provide an accreditation process analogous to those by which overseas toxicological societies recognise professional achievements (e.g. DABT. Members are again reminded that the process and fee structure for Registration is separate and distinct from the process of becoming a member of ACTRA.

Brian Priestly

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Asbestos Workshop 27th September 2009: Don’t miss out, register now!

As mentioned in the President’s report ACTRA and CRCCARE are organising a pre-conference short course on Asbestos management in soil. To find out more or register for the workshop go to http://www.cleanupconference.com/program.htm#Workshops

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ACTRA Annual General Meeting

When: 26^th September 2009, 6.30 pm

Where: Brian Priestly’s residence

Refer to President’s report for more information

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ACTRA Annual Scientific Meeting: 4th December 2009

When: 4^th December 2009, 8.30am – 5.00pm (times to be confirmed)

Where: APVMA Board Room 18 Wormald Street, Symonston, ACT, 2609

Cost to register: Members: $250

Non members: $320

Call for abstracts: A formal call for abstracts will be sent out shortly

Refer to President’s report for more information

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Short Course in Environmental Health Risk Assessment 23 - 25 Sept, 2009

Professor Brian Priestly is coordinating a short course on the principles of human health risk assessment and approaches to risk management and strategies for effective risk communication. More details can be obtained at http://www.med.monash.edu.au/epidemiology/shortcrs/2009/course-summary-enviro.html

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International Summer School Programme 2009 Environmental Risk Management

The University of Bolognia is coordinating a short course on the analytical and qualitative methods used in environmental and health risk management in Ravenna, Italy between the 4-11^th October 2009. More details can be obtained at http://g5.ambra.unibo.it/ERM2009/

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Scientific articles of interest

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Animal testing for cosmetics banned in Europe

On the 13th March 2009 an amendment to the European Union's Cosmetics Directive phased out the use of animals in testing for beauty products and toiletries (includes toothpastes, some sunscreens and shampoos). The amendment outlaws the use of animals in seven mandatory tests including skin irritation, photosensitisation, corrosivity, absorption through the skin, genetic toxicity, eye irritancy and acute toxicity. The amendment also bans the import of cosmetics containing ingredients that have been animal tested in this way after the deadline. Alternatives to four of the seven tests banned have been validated by the European Centre for Validation of Alternative Methods (ECVAM). The validated alternatives include methods for:

· photosensitisation (3T3 NRU phototoxicity test, OECD Test Guideline 432),

· absorption through the skin, In vitro tests for percutaneous absorption OECD Test Guideline 428)

· corrosion (CORROSITEX assay OECD Test Guideline 435, Rat TER skin corrosivity test OECD Test Guideline 430, and EpiDerm™ or EPISKIN™ skin corrosivity tests OECD Test Guideline 431)

Validated alternative models for other endpoints are not yet available however test methods that reduce the number of animals and degree of suffering have been approved for acute toxicity and skin sensitisation. These include:

· acute toxicity Up-and-Down Procedure OECD Test Guideline 425 Acute Toxic Class Method OECD Test Guideline 423 Fixed Dose Procedure OECD Test Guideline 420

· skin sensitisation Local Lymph Node Assay for skin sensitisation (LLNA) OECD Test Guideline 429

The consolidated European Cosmetics Directive and details on validated alternative tests can be found at the following URLs:

http://ec.europa.eu/enterprise/cosmetics/html/consolidated_dir.htm; http://ecvam.jrc.it/

Submitted by John Frangos

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Certification in Toxicology: International perspective

Brock, W., J., and Wooley A.P. (2009). Certification in Toxicology: An International perspective of risk:benefit. International Journal of Toxicology, 28(5): p 147-150.

“Registration, certification, accreditation – call it what you will – will become more important in the future and will have the effect of making toxicology a more overtly professional occupation..”

In light of the recent call for applications for listing on the ACTRA Register of toxicologists and risk assessment professionals, an editorial by Brock & Wooley (2009) is a timely summary of certification programs in toxicology around the world.

Brock & Wooley briefly describe the certification processes for the; American Board of Toxicology (ABT), Academy of Toxicological Sciences (ATS), the European Registered Toxicologist (ERT) and Japanese Society of Toxicology (JST). More importantly the authors discuss the benefits of registration/certification to the individual, their employers and the broader community.

All 4 schemes are broadly similar and offer the same benefits – worldwide recognition of experience and expertise in toxicology. Some of the features described by Brock & Wooley (2009) for each scheme are summarised below.

Feature	ABT	ATS	ERT	JST
Type of recognition	Certification	Certification	Registration	Certification
Assessment	Examination +Eligibility criteria	Eligibility criteria	Eligibility criteria	Examination +Eligibility criteria
Recertification required?	Every 5 years	Every 5 years	Active membership required	Every 5 years
Requirement for continuing education	20 hr/yr +exam every 5 yr	Not specified	50 hr/yr	Not specified

Brock & Wooley (2009) describe some of the benefits that result from a robust process of certification or registration for toxicologists, including:

· Leads to greater professional recognition amongst peers

· Offers a testimony to third parties about one’s ability to offer expert opinions

· Career advancement

· Some standards and statutes require assessment of safety to be conducted by a certified toxicologist

· Recognition of continued study and maintenance of expertise

Submitted by John Frangos

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News from other organisations and members

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New Australian regulator for the risk management of chemicals. Environmental Chemicals Bureau (ECB)

http://www.productstewardship.asn.au/documents/EPHC18__Communique_22May09.pdf

At the 18th Meeting of EPHC held in Hobart in May 2009, the Australian environment ministers made fundamental progress towards the establishment of an Environmental Chemicals Bureau for the risk management of chemicals in Australia.

Subsequent to a Productivity Commission Report into chemicals and plastics regulation in 2008, the Council of Australian Government has endorsed in principle a model for a proposed Environmental Chemicals Bureau: a lean, cost effective risk management body for making recommendations to the EPHC on chemicals in the environment. Establishing this body will close a significant gap in the current arrangements for environmental protection and will provide a consistent national approach to managing chemical risks in the environment. Consultation will be undertaken through 2009 on the proposed model to support the establishment of the Environmental Chemicals Bureau.

Submitted by John Frangos

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European Food Safety Authority adopts the benchmark dose approach

EFSA (2009). Guidance of the Scientific Committee on a request from EFSA on the use of the benchmark dose approach in risk assessment. The EFSA Journal (2009) 1150, 1-72. Published June 29. http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902629553.htm

The European Food Safety Authority has recently released a scientific evaluation and guidance document on the use of the benchmark dose (BMD) methodology for deriving toxicity reference values. The scientific review committee were asked whether the EFSA should use the BMD approach and under which circumstances this use would be appropriate. The Scientific Committee was also asked to provide some guidance on how to use the BMD approach for analysing dose-response data from experimental studies, and to look at the possible application of this approach to data from observational epidemiological studies. Finally, the Scientific Committee was asked to advise on whether the selection of appropriate uncertainty factors are needed when using the BMD approach for deriving a “Reference Point”.

Some of the important findings by the EFSA Scientific Committee include:

· The BMD approach is applicable to all chemicals in food, irrespective of their category or origin, e.g. pesticides, additives or contaminants. The BMD approach is of particular value for i) situations where the identification of a NOAEL is uncertain, ii) providing a Reference Point for the Margin of Exposure in case of substances that are both genotoxic and carcinogenic, and iii) dose-response assessment of observational epidemiological data.

· After comparing the strengths and weaknesses of the BMD and NOAEL approaches for deriving Reference Points for risk assessment, the Scientific Committee concluded that the BMD approach is a scientifically more advanced method to the NOAEL approach for deriving a Reference Point, because of the quantitative use of available dose-response data and quantification of the uncertainties in the dose-response data.

· the BMD approach was considered as the method of choice for the determination of the Reference Points for deriving health-based guidance values and margins of exposure.

· Health-based guidance values derived using the BMD approach can be expected to be as protective as those derived from the NOAEL approach, i.e. on average over a large number of risk assessments. Therefore the default values for uncertainty factors currently applied remain appropriate and there is no need for any additional uncertainty factor.

· Recommendations were made to incorporate BMD specific considerations into OECD Toxicity Test Guidelines and also to train EFSA staff in the use of the software tools currently available in order to fully implement the use of BMD at the EFSA within two years.

Submitted by John Frangos

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Contributions by individual members and opinions expressed within these contributions are not intended to nor do they represent the views of the Australasian College of Toxicology and Risk Assessment.

Diary of events

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ACTRA is actively planning several meetings in 2009. Members will be informed of these as the details become available. Details will be published in future e-news’ and on the website www.actra.org.au.

To view the diary of events, please click here.

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ACTRA Secretariat

Meetings First

4/184 Main Street

LILYDALE VIC 3140

Phone +61 3 9739 7697

Fax +61 3 9739 7076

Email actra@meetingsfirst.com.au