Seminário Nacional do Benzeno (5 e 6 dez/12) - AVALIAÇÃO DO RISCO CARCINOGÊNICO À SAÚDE HUMANA: MODELOS E ASPECTOS REGULATÓRIOS INTERNACIONAIS

1. 2nd day HM Bolt

2. Present state of benzene-induced
occupational disease in Germany
Hermann M. Bolt
Leibniz Research Centre for Working Environment and
Human Factors at the TH Dortmund, Germany

3. Historical Developments in Germany
✽ after end of 18th century:
✽ mechanization of production
✽ freedom of occupation and trade
(end of guild system)
✽ consequences:
✽ decreasing importance of handicrafts
✽ development of factory system
✽ child labor, night labor, shift work

4. Early Governmental Regulations in Germany
✽ 1839 First occupational safety law in Prussia:
Prussian child protection law
✽ 1845 Prussian Trade Law: Founding of health
insurance companies for factory workers
✽ 1853 Factory inspectors
✽ 1881 „Imperial Message“

5. Otto von Bismarck
Chancellor of the German Reich
„Der eiserne Kanzler“
1815 - 1898

6. Bismarck‘s appeal to parliament
(Reichstag) on May 9th 1884
✽ Give the worker the right to work, as long as
he is healthy
✽ Ensure that he is nursed when he is ill
✽ Secure him a living when he is old

7. Keystones of Bismarck‘s Social Legislation
✽ Imperial Message of Nov. 11th 1881
(birth of the German social security system)
✽ 1883 Health Insurance Law
compulsory insurance
✽ 1884 Occupational Accident
Insurance
✽ 1889 Invalidity Insurance Law
Pensions at age 70, disability pensions

8. Occupational Accident Insurance
✽ Organization: Deutsche Gesetzliche
Unfallversicherung (DGUV)
✽ Berufsgenossenschaften
✽ More than 25 associations according to trades
✽ e.g. Chemical Industry
✽ Metal industry
✽ Civil administration
✽ Health care
✽ Agriculture
✽ Shipping
✽ State and Federal Insurance Associations
✽ for civil servants and students

9. Occupational Accident Insurance
✽ Membership
✽ Only employers are members
✽ Compulsory membership if there are any
employees
✽ No compulsory membership for self-employed
persons
✽ Employees are not members but „insured
persons“

10. Aspects for the individual
✽ Acknowledged occupational accident or
disease
✽ Superior quality of treatment
✽ Unlimited continuation of payment of wages
✽ Vocational retraining if necessary
✽ Compensation for loss of income
✽ Indemnities payed in addition to pensions (old age,
disability) or to occupational income

11. Procedure of confirmation (acknowledgement)
of occupational disease (I)
✽ Suspected occupational disease is reported
to the insurance by a physician, by the
employer, or by a health insurance
company
✽ Every physician or dentist and every
employer is legally obliged to report a case
of suspected occupational disease

12. Procedure of confirmation (acknowledgement)
of occupational disease (II)
1 Report of case
2 Occupational accident insurance decides to
investigate or to refute the case due to formal
reasons or extreme lack of plausibility
3 Investigation of occupational history, conditions of
the worksite (exposure etc.), collection of data
(measurements etc.) and medical reports
4 - Technical report
- opinion of government medical officer
- independent medical expertise (opinion)
5 Decision by a board of trustees (representatives of
employers and trade unions)

13. Procedure of confirmation (acknowledgement)
of occupational disease (III)
✽ Primary decision of insurance association
✽Contradiction by insured person
✽ Final decision of insurance company
Law suit
primary court
court of appeal
etc.

14. How is an occupational disease established?
✽ In general:
✽ Only those diseases which have been officially
recognized by the Federal Government can be
compensated
✽ Official List of Occupational Diseases

15. Specific apects of occupational diseases
✽ The list of occupational diseases is based on the recommendations of
a scientific committee
✽ The Federal Government is free to exclude diseases from the list or to
place specific restrictions on acknowledgement
✽ Restriction to certain occupations, limit dose for cumulative
exposure etc.
✽ The risk factor must be certain
✽ A statistical association between an occupation and a disease
is not sufficient
✽ Group justice, not individual justice
✽ The eligible group must be exposed to the risk factor to a higher degree
than the rest of the population.
✽ However, courts have ruled that in general this higher
exposure should lead to a higher risk of illness, in general
doubling the relative risk or odds ratio!

16. German List of Occupational Diseases (BK List)
✽ 65 enumerated entities, classified in 6 groups
1. Diseases caused by chemical factors (e.g. benzene)
2. Diseases caused by physical factors
3. Diseases caused by infectious agents or parasites
4. Diseases of the airways, the lung, the pleura and the
peritoneum
5. Skin diseases
6. Other diseases

17. Official prodecure for a new BK
 New scientific knowledge
 Medical Committee Occuptional Diseases at the
Federal Minister for Work and Social Affairs
 Official Publication by the Federal Minister (GMBl)
 Official introduction of the new BK by the Minister

18. New BK 1317 for benzene since 2009

19. Key points from the Scientific Justification of BK 1318
„Occupational benzene exposures can induce non-
malignant and malignant diseases of the blood and
lymphatic system. The primary effect is suppression of
blood cell formation due to toxic bone marrow depression.“
„Because of the pathophysiological mode of action that
includes alteration of the haematopoetic stem cell pool,
benzene can cause all haematolymphatic system diseases
of which the cells are derived from the omnipotent stem
cell. Chronic long-term occupational exposure is a pre-
condition (Schönberger, Mehrtens, Valentin, 7th ed, 2003).“

20. From the Scientific
Justification
of BK 1318

21. Specific diseases under BK 1318
Toxic damage of the bone marrow:
„leukopenia, lymphopenia, thrombocytopenia, pancytopenia“
Aplastic anaemia and myelodysplastic syndrome
Leukaemia
Non-Hodgkin lymphoma (!)
Myeloproliferative diseases:
„CML, polycythaemia vera, essential thrombocythaemia,
osteomyelosclerosis“

22. From the Scientific
Justification
of BK 1318

23. Scientific Justification of BK 1318:
cut-off point for compensation of leukaemia = 10 ppm-years
!!!!
!!!!

24. Leukemia and „stem-cell near“ non-Hodgkin lymphomas*:
Hints for retrospective exposure evaluation (sufficient for BK 1318?)
Listing typical work situations of
-extreme 1y sufficient for compensation
-high 2-5 y sufficient for compensation
-medium 6-10 y sufficient for compensation
-low evaluation case-by-case
benzene exposures (related to the time of exposure,
in view of increasing regulatory limitations for benzene)
*Limit of 10 ppm-years also for CLL, aplastic anemia and
myelodysplastic syndrome!

25. From the Scientific Justification of BK 1318:
„conditions of extreme exposure intensity“ – 1 year sufficient
 Open gasoline puming (ships, trucks, container) until 1982
 Benzene alkylation and ethyl benzene synthesis in the former GDR
 Cleaning (also hand cleaning) with gasoline until 1985
 Spraying with benzene containing solvents (before 1970)
 Working in tar, pitch, asphalt laboratories (extractions with benzene)
(before 1970)
 Cleaning of gasoline tanks until 1980
 Cleaning of benzene tanks/containers

26. From the Scientific Justification of BK 1318:
„conditions of high exposure intensity“ – 2-5 years sufficient
 Working in cokeries or gasworks before 1990 (2 y) or before 1999 (4 y)
 Benzene manufacturing before 1999 (4 y)
 Working in plants for ethylene synthesis before 1990
 Servicing gasoline tanks before 1999 (4 y)
 Servicing benzene containing pipelines or pumps until 1999 (4 y)
 Servicing automobiles / gasoline containing parts until 1980 (2 y)
 Servicing automobile carburettors until 1985 (2 y)

27. From the Scientific Justification of BK 1318:
„conditions of medium exposure intensity“ – 6-10 years sufficient
 Working in benzene extraction or processing until 1990
 Filling gasoline into trucks or vessels since 1990
 Filling gasoline into trucks or vessels until 1990 (7 y)
 Driving gasoline trucks until 1999
 Closed loading of gasoline (vessels) since 1982
 Unloading in foundries
 Laboratory analytical work with gasoline (6 y)
 Laminating with benzene-containing solvents (1970-1979)

28. From the Scientific Justification of BK 1318:
„conditions of low exposure intensity“ – evaluation case by case
 Exposure as bystander in cokeries; petrochemical industry works
 Fuelling automobiles after 1970
 Cleaning tanks for Diesel/heating oil or kerosine (ca. 0.004 vol% benzene)
 Handling solvents with <0.1 % benzene after 1980 (West Germany)
 Other solvent mixtures containing benzene: case by case evaluation

29. Non-Hodgkin lymphoma (including multiple myeloma)
and myeloproliferative disorders, including CML
„For the rest of the listed diseases a sufficient exposure is
assumed for conditions of
extreme exposure intensity of 2-5 y, or of
high exposure intensity of 6 and more years,
although the present epidemiological evidence is insufficient.“

30. Benzene-induded occupational disease in Germany
(BK 1303 + 1318 combined, http://www.dguv.de)
Year BK acknowledged New pensions Deaths
2008 110 98 43
2009 168 152 46
2010 186 174 51
Average costs to the system per case: € 100,000.--

31. Own experience at IfADo
giving independent medical expertise (opinion) on pending BK 1303/1318 cases
since 2007 [official publication GMBl dated 1 Sep 2007]: 33 cases

32. Cases reviewed at IfADo, 2007-2012
Year MDS AML CLL CML Mult.myel. B-cell-NHL T-cell NHL
2007 1 - - - 1 - -
2008 2 - 2 - 1 6 -
2009 1 - 1 1 1 4 -
2010 3 1 - - 1 -
2011 3 - - - - 2 -
2012 2 2 - 1 - - 1
(Jan-Nov)
Total 12 3 3 2 4 8 1
Grand total: 33 cases, 2007-2012: 28 cases recommended for compensation,
5 cases not recommended (mostly because of only low benzene exposure)

33. Cases reviewed at IfADo, 2007-2012
Cumulative benzene exposure of our BK 1303/1318 cases:
mean 22.7 ppm-years
[range 3.2 – 174 ppm-years]
Thank you for your attention!

34. Acknowledgement
to my colleagues in occupational medicine (and former coworkers): T. Brüning
(Bochum), V. Hath (Homburg/Saar) and E. Hallier (Göttingen, not on the picture),
all having significantly contributed to benzene
Perekop, Luxemburg