W507 – Regulatory Considerations

1. W507 – Regulatory Considerations

2. Risk and safety phrases • Users need information on the hazards of substances to undertake risk assessments and to apply suitable control measures • Material safety data sheets • Standard and accuracy of data sheets may vary • Becoming more consistent in format and standard • Labels attached to the products • Globally harmonised system (GHS) being developed and implemented in many countries

3. Globally harmonised system • Internationally comprehensible system for hazard communication • Reduce need for testing and evaluation of chemicals • Facilitate international trade in chemicals by ensuring hazards have been properly assessed and identified to international standards • Pictograms are a key hazard communication tool

4. Pictograms (GHS)

5. Pictograms (GHS) • Give immediate indication of type of hazard • Pictograms supplemented by signal word ‘Danger’ or ‘Warning’ depending on severity of hazard class • Pictograms supported by standardised hazard statements and precautionary statements

6. Material safety data sheets (MSDS) • Hazard information on a substance or preparation should be provided by the manufacturer or supplier • Used as starting point for risk assessments • Should conform to a standardised structure with different sections for specific information types • However, the quality and quantity of information on a MSDS varies widely between different suppliers

7. Material safety data sheets (MSDS) • Section 1 – Identification of substance / company • Chemical name including trade names • Name, address and contact numbers (including e-mail contact) of company • Section 2 – Hazards identification • Hazard description, including risk and safety phrases and codes • Section 3 – Composition of mixtures • Chemical identification numbers (CAS, EU etc) • Information on each component of mixtures • Section 4 – First aid measures

8. Material safety data sheets (MSDS) • Section 5 – Fire fighting measures • Section 6 – Accidental release measures • Section 7 – Handling and storage • Section 8 – Exposure controls / personal protection • Any regulatory exposure standards • Information on suitable types of personal protective equipment • Section 9 – Physical and chemical properties • Section 10 – Stability and reactivity

9. Material safety data sheets (MSDS) • Section 11 – Toxicological information • Results of toxicological tests • Health effects associated with the substance • Any evidence of carcinogenicity • Section 12 – Ecological information • Section 13 – Disposal considerations • Section 14 – Transport information • Section 15 – Regulatory information • Lists the hazard codes, risk phrases and safety phrases • Section 16 – Other information

10. Group work – data sheets • In your allocated groups examine the data sheets for the following substances • 2-methoxyethanol • Methyl ethyl ketone • Titanium dioxide • For each identify the following • Health effects / hazards • Routes of entry of concern • Recommended controls • Exposure limits

11. Group work – data sheets • Identify any differences between the data sheets • Are they easy to use / clear? • If not - how they could be more useful to you as a user of the hazardous substance? • Report back to the whole class

12. Other information sources • Important that the hygienist can access accurate and unbiased information • Risk assessment, risk management and hazard communication all require objective information • It is becoming an increasingly important part of the hygienist’s role to interpret and communicate hazard and risk information

13. Other information sources • Peer-reviewed scientific literature • Potentially the most credible source of information, where findings have been reviewed by other experts • Published in professional journals • e.g. Annals of Occupational Hygiene • Articles tend to be very technical and often it is sufficient to use the article summary

14. Other information sources • Governmental and other recognised organisations • Credible sources of information include government publications, approved codes of practice and guidance notes • Other widely respected non-government organisations • e.g. WHO, ILO, IARC • Occupational Health and Safety Databases • Some are free, some require subscription • Professional Associations • E.g. BOHS, AIOH, AIHA, IOHA, SAIOH

15. Other information sources • Many other potential sources of information published on the internet • Care needs to be taken to ensure that the information is valid – particularly from sources that are self published as they may represent personal or organisational views that may or may not be supported by scientific evidence • Similarly articles may be published in newspapers that have not been peer reviewed • Workers and members of the public also have access to a wide range of information

16. ‘Laser printers’ case study

17. Laser printers – health concerns • Based on an actual series of e-mails regarding health concerns related to particle emissions from laser printers • Initial concerns raised by article in a National newspaper • Review e-mails 1 and 2 • Initial thoughts? • How would you would deal with the enquiry?

18. Laser printers – health concerns • Review e-mails 3 and 4 • Is the approach of John appropriate? • Could he have done anything else? • Review e-mails 5 and 6 • Is the approach of Tim appropriate? • Could he have done anything else?

19. Laser printers – health concerns • Read the press release from xxx University • Read the abstract of the study • Do you think the study findings support the health concerns raised? • Do you think the press release supports the health concerns raised? • Review e-mails 7 and 8 • Are the replies of John and Tim appropriate? • E-mail 9 – here we go again!

20. Laser printers – health concerns • Lessons learned? • Need to respond to concerns promptly as the concerns can rapidly escalate through an organisation • Need for objective analysis of facts • Need to get back to original source of information • Need to critically evaluate validity of study • Need to critically evaluate interpretation of results of study

21. Strategic Approach to International Chemicals Management (SAICM) • Chemicals are traded internationally and as chemical safety is a global concern this has led to a number of international initiatives • SAICM was launched in 2006, involving more than 140 countries • SAICM aims to ensure that chemicals are used and produced in ways that minimise significant adverse effects on human health and the environment

22. Registration, Evaluation, Authorisation and Restriction of Chemicals Regulations (REACH) • REACH is intended to • Help the European Union achieve the objectives of SAICM • Streamline the previous legislative framework • REACH applies to all European countries and many other countries are likely to adopt the same (or similar) approach

23. Registration, Evaluation, Authorisation and Restriction of Chemicals Regulations (REACH) • REACH makes industry (producers and importers) responsible for • Assessing and managing risks posed by chemicals • Providing safety information to users • Requires registration of substances produced / imported in quantities greater than 1 ton • Requires comprehensive information to be gathered on the properties of the substance • Submission of technical dossier containing information on the chemical and how to effectively manage the risk

24. Registration, Evaluation, Authorisation and Restriction of Chemicals Regulations (REACH) • Specific authorisations may be required for substances of very high concern • Carcinogenic, mutagenic and toxic to reproductive system (CMR) • Substances with persistent, bio-accumulative or toxic properties (PBT, vPvB) • Authorisations may only be granted if no safer alternative exists and the socioeconomic benefits of the use outweigh the risks

25. Registration, Evaluation, Authorisation and Restriction of Chemicals Regulations (REACH) • All substances produced in quantities of 10 tons or more per year require manufacturers to prepare • Chemical Safety Assessment (CSA) • Chemical Safety Report (CSR) • If the Chemical Safety Assessment shows the substance to be dangerous or of very high concern manufacturers are required to • Generate Exposure Scenarios (ES) or risk assessments for all identified uses of the substance • These should consider the potential adverse effects and take into account recommended risk management measures

26. Registration, Evaluation, Authorisation and Restriction of Chemicals Regulations (REACH) • Downstream users have a duty to:- • Use the substance according to the risk management measures • Inform the manufacturer how they use the substance if different to the documented exposure scenarios with the aim to make it an identified use • There is a phased introduction for REACH • Overall management of REACH is responsibility of the European Chemicals Agency (ECHA) in Helsinki