Health & Safety During The Installation of Polyurethane Resin Flooring Presented By: Dr Derrick Hulett

1. Health & Safety During The Installation of Polyurethane Resin Flooring Presented By: Dr Derrick Hulett Group Compliance Manager – John Lord Group of Companies Member of FeRFA Technical Committee

2. CONTENTS Background Recent Developments Control Measures John Lord Approach References

3. 1.Background • Current Health & Safety Fears • Is the MDI in polyurethane resin a Carcinogen? • Does the MDI also cause industrial Asthma? • Does the dust in the aggregates cause Silicosis? • Is the only safe way of protecting against these threats is to wear positive pressure full face respirators • Origin of the Health & Safety Issues • MDI exposure study reported in the Journal of Toxicological Science (1994) • EU MDI Risk Assessment Report • Reclassification of MDI’s (2005) • HSE’s Involvement • Fit3 Disease Reduction Programme • Dust & Fume Project • REACH

4. 1.Background • MDI as a Carcinogen • In 2008 the 30th Adaptation to Technical Progress (ATP) of the Dangerous Substances Directive classified MDI (CAS No. 26447-40-5) as R40 – Category 3 carcinogen “Limited evidence of a Carcinogenic effect.” • In December 2010 the CLP regulations classified MDI as H351: Suspected of causing cancer by inhalation. Cat 2 Carcinogen “substances which it is assumed can cause cancer, on the basis of reliable animal evidence.” • However • Different CAS Number (9016-87-9) • Animal study not representative of substance used in flooring. (to be discussed later)

5. 1.Background • MDI as a cause of Asthma • There are approximately 17,000 new cases of occupational asthma each year . • One major cause is the inhalation of MDI mists particularly in the 2 pack isocyanate paint spraying of vehicles. • However • In paint spraying the particle size and the aerosol state enables the isocyanate to be inhaled. This is not the case with the MDI used in polyurethane flooring.

6. 1.Background • Silicosis from Dust in Aggregates • Workers exposed to fine dust containing quartz are at risk of developing a chronic and possibly severely disabling lung disease known as "silicosis". • In addition to silicosis, there is now evidence that heavy and prolonged workplace exposure to dust containing crystalline silica can lead to an increased risk of lung cancer. The evidence suggests that an increased risk of lung cancer is likely to occur only in those workers who have developed silicosis. • However • Excessive long term exposures to almost any dust, are likely to lead to respiratory (breathing) problems. • Preventing inhalation through the use of a simple FFP3 dust mask (face fit tested) will remove the problem.

7. 1.Background • Use of Full Face (Air Fed) Respirators • Respirator manufacturers will advise that the only truly safe form of respirator against respirable MDI is an air fed mask which does not contain standard filters. • The reason for this is that although filters such as “Abek” and even FFP3 will filter out the MDI, the breakthrough period cannot be established. • However • The MDI used is not respirable.

8. 1.Background • MDI Exposure Study • In 1994 an article was produced for the Toxicological society describing MDI inhalation tests carried out on 60 Wistar rats (Reuzel et al 1994). • One conclusion was that chronic exposure to polymeric MDI at a level of 6.0 mg/m3 was related to the occurrence of pulmonary tumours. • However • 60 rats were tested over a two year period. • The MDI was aerosolised to make it inhalable. • Exposures at other levels (0.2 & 1.0 mg/m3) did not lead to any tumours. • Only 1 rat at the 6.0 mg/m3 dose developed a pulmonary tumour. • Some of the rats developed other tumours totally unrelated to the study.

9. 1.Background • EU MDI Risk Assessment • In 2005 a department of the Belgian government carried out a risk assessment on behalf of the European Union into MDI (CAS No. 26447-40-5) . • Among the conclusions from the assessment it was stated that “There is a need for limiting the risks” to workers and consumers who come into contact with this type of MDI. • This assessment undoubtedly influenced the subsequent reclassification of MDI MDI(CAS No. 26447-40-5) . • However • The risk assessment used the findings of the study by Reuzel et al. • Once again, different CAS Number (9016-87-9)

10. 1.Background • Reclassification of MDI • As mentioned earlier 30th ATP of the Dangerous Substances Directive classified MDI (CAS No. 26447-40-5) as R40 – Category 3 carcinogen “Limited evidence of a Carcinogenic effect” and the CLP regulations classified MDI as H351: Suspected of causing cancer by inhalation. Cat 2 Carcinogen “substances which it is assumed can cause cancer, on the basis of reliable animal evidence.” • However • Different CAS Number (9016-87-9) • As stated by ISOPA “There will be no impact on workplace health and safety from this change beyond what is good practice today.”

11. 1.Background • HSE Involvement – DRP • In 2002 the HSE agreed its “chemicals strategy” and programmes of work were set up to address disease reduction and management in 3 areas: (Cancer, Respiratory disease and Skin disease. • Since 2004/5 the work has continued under the HSE's Disease Reduction Programme (DRP). • The objective of the Disease Reduction Programme is to deliver reductions in the incidence of ill health related to chemicals in the workplace. • The approach is to target industries for inspection based on the perceived size of the problem.

12. 1.Background • HSE Involvement – Dust & Fume Project • The Respiratory Diseases Unit within the Long Latency Health Risks Division (LLHRD) are working on a ‘Dust and Fumes Project’, which aims to reduce the incidents of respiratory disease by raising awareness of the long term health effects of inhaling dust and fumes in the workplace. • Using information gathered over a number of years, five ‘high risk’ industries have been identified for targeted campaigns – (stoneworking, construction, foundries, quarries and welding.)

13. 1.Background • HSE Involvement – REACH • On 22nd June 2009Annex XVII to Regulation (EC) No 1907/2006 (REACH Regulations) was amended by Commission Regulation (EC) No 552/2009. • In the amended Annex XVII, substance No. 56. Methylenediphenyldiisocyanate (MDI) CAS No 26447-40-5 EC No 247-714-0 was amended as follows. • 1. Shall not be placed on the market after 27 December 2010, as a constituent of mixtures in concentrations equal to or greater than 0,1 % by weight of MDI for supply to the general public, unless suppliers shall ensure before the placing on the market that: • Gloves provided • Warning notices regarding sensitisation, asthma, ventilation and type 1 masks (ABEK) • Comment • The above points in bold highlight some of the confusions

14. 1.Background • HSE Involvement – REACH • HSE is the competent authority (CA)for assessing REACH Compliance in the UK. • HSE have issued the following statement regarding their future work as the REACH CA: • Targeted inspection campaigns • This year sees the launch of a series of substance-specific inspection campaigns. These campaigns will identify dutyholders on the basis of detailed intelligence on supply chain activity surrounding the substances subject to inspection. By comparing this intelligence to records of registration and pre-registration, we will be able to target and approach those dutyholders that appear to be in breach of the core requirements in REACH to register substances ('no data, no market[8]'). In addition, this will present us with opportunities to assess compliance with other aspects of REACH.

15. 2.Recent Developments • ISOPA Position Paper • HSE Laboratories Research Document HSL/2005/60 • FeRFA Consultation with HSE

16. 2.Recent Developments • ISOPA Position Paper • ISOPA is the European Diisocyanate and Polyol Producers Association. • In May 2011 ISOPA produced a document entitled: Timeline For The Re-classification And Labeling Of MDI As Substance And Mixtures. • Conclusions of the paper include: • The concentration required to cause tumours in the lungs of the test animals was 6 mg/m³, which is more than 100-times the MAK-value (0.05mg/m³). These aerosols had to be respirable, what means that the droplets need to have a so-called aerodynamic diameter of 10 μm. • The particle size, even of aerosol droplets, in industry are massively larger than this (in excess of 40 μm) making them not respirable. • Health surveillance programmes involving around 12,000 workers in the MDI processing industry did not show any increased risk of lung cancer.

17. 2.Recent Developments • HSE Laboratories Research Document HSL/2005/60 • Tests were carried out on diisocyanates in 2-pack paint systems. • Although not the exact same process as involved in the installation of polyurethane resin flooring it is representative. • The following conclusions were arrived at: • The laboratory tests found no airborne isocyanate during small scale mixing and brush and roller application. • The static samples were carried out close to the operations under test and so represent a "worst-case" series of results. • These results suggest that airborne isocyanate is not a significant hazard during these operations • The biological monitoring results associated with this work found no evidence of isocyanate exposure suggesting that the personal protective equipment (PPE) worn during these operations was adequate to prevent exposure.

18. 2.Recent Developments • FeRFA Consultation with HSE • FeRFA is the Resin Flooring Association and represents manufacturers and installers of polyurethane resin flooring. • On the 14th June 2011 members of the Technical Committee of FeRFA met with representatives of HSE including HM Principal Specialist Inspector, Head of Health Risks, Management Unit. • At the meeting FeRFA presented evidence broadly as outlined in this presentation and specifically: • Referred to the MDI Exposure study by Reuzel et al (1994) and commented that the tests had been carried out at 300 times the Occupational Exposure Level using a specially prepared finely dispersed respirable aerosol. • It was also stated that: • MDI is not aerosolised in flooring applications • MDI has very low vapour pressure

19. 2.Recent Developments • FeRFA Consultation with HSE • FeRFA produced evidence to show that: • MDI is not aerosolised in flooring applications • MDI has very low vapour pressure • The reclassification of MDI has no impact on workplace health & safety beyond what is good practice today. • There is no risk of aerosol isocyanate in normal use of the products as flooring materials • The UK Occupational Exposure Limit (OEL TWA) = 0.02mg/m3 in an 8 hour period, test • results show less than 3% of the OEL during an 8 hour working period. • During the meeting an agreement was reached as to the control measures required during the installation of polyurethane resin flooring.

20. 3.Control Measures • Based on the evidence presented and following the Consultation with HSE the following control measures should be adopted to provide protection against any health hazards during the installation of polyurethane resin flooring. • Method statement and risk assessments • COSHH assessments • MSDS if required • Lung function health surveillance • Segregation • FFP3 disposable respirators for mixing and floor preparation • Respirators not required for MDI • PPE to prevent skin contact with MDI

21. 4. John Lord Approach • The following is a list of Control Measures adopted by John Lord • Every site has a method statement, risk assessments and COSHH assessments detailing specific control measures. • Lung function health surveillance is carried out on all persons exposed to MDI and Crystaline Silica (helps early detection of COPD). • Wherever possible ask for persons not essential to the process of installing the resin flooring to be segregated from the activity (this is mainly to remove the risk of skin contact with the MDI and to reduce the possibility of spillages). • FFP3 masks worn when mixing and when creating dust through floor preparation. Face fit testing carried out. • Overalls, Impermeable gloves, Safety glasses, Safety boots or shoes, • Special provisions regarding hard hats and glasses for floor layers

22. 5. References Reuzel, P.G.J, J.E.H Arts, L.G. Lomax, M.H.M Kuijpers, C.F. Kuper, C. Gembardt, V.J. Feron and E. Löser 1994, Chronic Inhalation Toxicity and Carcinogenicity Study of Respirable Polymeric MethyleneDiphenylDiisocyanate (Polymeric MDI) Aerosol in Rats, Toxicol. Sci. (1994) 22(2): 195-210 http://toxsci.oxfordjournals.org/content/22/2/195.short ISOPA, 2011, Timeline For The Re-classification and Labellingof MDI as Substance and Mixtures, May 2011 http://www.isopa.org/isopa/uploads/Documents/documents/Timeline%20for%20Re-C&L%20of%20MDI%20as%20subtance%20and%20Mixtures.pdf ISOPA, 2011, EU, MDI-containing Consumer Products, May 2011 http://www.isopa.org/isopa/uploads/Documents/documents/Customer%20Information%20MDI%20Risk%20Management%20%20EU%20Restrictions.pdf

23. 5. References Coldwell, M. and J. White, 2005, Measured Airborne Isocyanate from Mixing and Brush and Roller Application of Isocyanate based 2-pack Paints, Results - February 2005, HSL/2005/60 http://www.hse.gov.uk/research/hsl_pdf/2005/hsl0560.pdf European Commission – Joint Research Centre, Institute for Health and Consumer Protection, European Chemicals Bureau (ECB), European Union Risk Assessment Report - methylenediphenyldiisocyanate (MDI)- CAS No: 26447-40-5 EINECS No: 247-714-0, Series: 3rd Priority List Volume: 59 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:164:0007:0031:EN:PDF Commission Regulation (EC) No 552/2009 Amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII, 22 June 2009 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:164:0007:0031:EN:PDF

24. 5. References Commission Directive 2009/2/EC, Amending, for the Purpose of its Adaptation to Technical Progress, for the 31st Time, Council Directive 67/548/EEC on the Approximation of the Laws, Regulations and Administrative Provisions Relating to the Classification, Packaging and Labelling of Dangerous Substances, 15 January 2009 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:011:0006:0082:EN:PDF Commission Directive 2008/58/EC, Amending, for the Purpose of its Adaptation to Technical Progress, for the 30th Time, Council Directive 67/548/EEC on the Approximation of the Laws, Regulations and Administrative Provisions Relating to the Classification, Packaging and Labelling of Dangerous Substances, 21 August 2008 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:246:0001:0191:EN:PDF FeRFA 2011, Reclassification of MDI, 16 June 2011 http://www.ferfa.org.uk/html/pdf/ReclassificationMDInote.pdf