1. European Commission, DG Environment Air & Industrial Emissions Unit
Study to assess likelihood and consequences of major accidents involving acute toxic 3 dermal substances - results
European Commission, DG Environment
Air & Industrial Emissions Unit

2. Background – scope of Seveso III
EC proposal for Seveso III ('Health hazards')
- Acute Toxic 1 and 2, all exposure routes
- Acute Toxic 3: dermal and inhalation (not oral) - STOT SE category 1
Directive 2012/18/EU excludes acute toxic 3 dermal
Declaration EC – further assessment acute toxic 3 dermal (AT3 dermal) major accident potential

3. Methodology of the study
Study AMEC - August June 2013
(1) compare frequency/consequences of accidents involving AT3 dermal and AT3 inhalation substances based on
Data on major accidents of past 10 years
Analysis of relevant major accident scenarios
Survey
(2) Assess economic impact of inclusion

4. Results questionnaire
1/3 of respondents aware of past accidents/near misses involving dermal toxic effects
Only a few scenarios involving AT3 dermal substances identified – not enough detail
Very difficult/impossible to answer question on number of establishments potentially affected by a change in scope
On-line survey – 1000 stakeholders approached - questionnaire sent to registered participants - 21 answers - good balance of industry(associations)(57 %), public authorities (23 %), academic and consulting companies (19 %) – no ‘representative sample’ but good expert advice on 'niche' issue
Direct enquiries with relevant suppliers registered under REACH by the 2010 deadline (high tonnage >1000t chemicals per year
Little information on potential impacts of including acute toxic 3 in scope Seveso
• 27 AT3 dermal substances identified which are not covered by Seveso Directive due to other properties
• Half of respondents consider that these substances have a major accident potential – but accidents would be less significant than accidents involving other exposure routes (e.g. inhalation)

5. Results questionnaire
Activities most likely to be concerned
Chemical installations
Plastic and rubber manufacture
Production/storage of pesticides, biocides, fungicides
Production of basic organic chemicals
Production of pharmaceuticals
Based on cost/benefit analysis, majority of respondents not in favour of including AT3 dermal substances in the scope of Seveso.

6. Identification of relevant substances
Search of C&L Inventory (ECHA database of chemicals classified under CLP Regulation) =›
41 substances with harmonised classification AT3 dermal and NOT also AT3 inhalation
15 of these are AT3 dermal and not also classified for other Seveso relevant hazards
Many more substances self-classified AT3 dermal but scope of study does not allow to estimate

7. Analysis of past accidents
Review of (inter)national accidents databases – period 2000 to 2012
Of over accidents, 800 accidents involving toxic substances
57,4 % involved inhalation exposure
3,6 % involved dermal exposure route
Remaining 39 %: no/not known toxic effects

8. Analysis of past accidents
Accidents involving dermal exposure led to lower human consequences (fatalities and injuries) than those involving inhalation exposure
Of all accidents with only dermal exposure, only one death occurred (on-site, i.e. occupational)
Large number of accidents involving inhalation exposure generated one or more deaths
None of the accidents involving dermal exposure had consequences outside the establishment against 65 accidents involving inhalation exposure with off-site consequences

9. Analysis of accident scenarios
5 accident scenarios – substances falling within categories AT3 dermal and AT3 inhalation Substances selected in order to represent a wide range of toxicity values to ensure that results are representative for as wide a range of substances possible (LD50 values for AT3 dermal range between /kg and LC50 values for AT3 inhalation vapour range between 2 and 10 mg/l)

10. Analysis of accident scenarios
Toxic exposure (dermal) 1
Vessel rupture – spreading of pool and evaporation – establishment of a vapor cloud
Exposure to a toxic cloud 2
Vessel rupture – spreading of pool
Direct exposure to the product (liquid) 3
Vessel pneumatic rupture – projection of product - « rain » of product
Direct exposure to the product (“ rain”) 4
Vessel rupture – spreading of pool and dilution in water
Indirect exposure (liquid diluted in water) 5
Pipe rupture – release of product under pressure – projection of product
Direct exposure

11. Analysis of accident scenarios
For 4 scenarios, the distances at which lethal effects are likely to be felt are (far) greater for toxic inhalation than for toxic dermal (by a factor of between 1.1 and 1000) - vapours more likely to reach people than liquids - long exposure duration and massive exposure of skin needed to reach 50% lethality level
No significant difference for scenario n° 5 as consequences not only depend on LD50/LC50 (inherent dangerous properties) but also on other parameters (solubility, density, topology of body of water) – not assessed

12. Cost/benefit analysis
Based on extrapolation of figures from UK, DE and FR (together representing almost half of all Seveso establishments), it is estimated:
500 establishments could newly come into scope
Overall additional cost between €10 million to €60 million per year (based on assumptions of per-establishment costs and number of establishments affected)
This does not include
Costs of technical modifications to plant/equipment (too variable/uncertain)
Administrative costs for authorities (inspections, emergency plans...)
Covering AT3 dermal could impact viability of SMEs

13. Cost/benefit analysis
Value of a statistical life concept (VOSL) – ranges between €1 and €2 million (EC impact assessment guidelines)
=› a measure costing €2 million/year would be justified if it would allow to save at least one life a year
=› in case of AT3 dermal, since cost of inclusion estimated to be between €10 mio and €60 mio/year, it would be justified if it allowed to save at a minimum 5 deaths a year (lowest cost divided by highest estimate of VOSL)
Accidents caused by "only" AT3 dermal have not -in the past- led to this amount of deaths

14. Conclusions
1. Review of past accidents shows that significantly more accidents in recent years involved the inhalation exposure route than the dermal exposure route
2. Accidents involving the toxic dermal exposure route tend to lead to lower human consequences (fatalities/injuries) than accidents involving the toxic inhalation route

15. Conclusions
3. Analysis of accident scenarios suggests that serious accidents involving AT3 dermal are
less likely to occur
unlikely to produce the same harmful/lethal consequences in the even that they do occur
Eventual consequences of accidents involving AT3 dermal would be on-site, rather than off-site, therefore covered by Health and Safety Legislation
The cost/benefit analysis shows that the costs of covering dermal would not be proportionate