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Proceedings of the International Conference on
Occupational & Environmental Exposures of Skin to Chemicals:
Science & Policy
Hilton Crystal City     September 8-11, 2002
 

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Protecting Workers from Dermal Exposure - The German Experience

Eva Lechtenberg-Auffarth, PhD, Federal Institute for Occupational Safety and Health (BAuA), Dortmund, Germany
Bruno Orthen, PhD, Federal Institute for Occupational Safety and Health (BAuA), Dortmund, Germany (Corresponding Author)

Skin diseases
Skin diseases are the most frequent occupational diseases in Germany. About 20000 suspected occupational skin diseases were communicated to the statutory accident insurance institutions in 2000. Each suspected case is estimated to produce costs mounting to 14000 €. If skin diseases are confirmed to have an occupational origin (ca. 8000 in 2000) or if workers have to give up their occupation (ca. 450 in 2000) allowances are significantly higher. These figures only reflect cases of irritative and allergic contact dermatitis, systemic effects via the dermal route are not included.

Legal framework
A broad legal framework for risk characterisation and protective measures against (dermal) risks of chemical agents exists which is in close relation to the EU legislation

German legislation EU legislation
Arbeitsschutzgesetz (Act on Workers´Health Protection) from 7.8.1996 Council Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work
Gefahrstoffverordnung (Hazardous Substances Ordinance) from 7.8.2000 Council Directive 98/24/EEC on the protection of the health and safety of workers from the risks related to chemical agents at work
PSA-Benutzungsverordnung (Ordinance on Use of PPE) from 4.12.1996 Council Directive 89/656/EEC on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace
Gefahrstoffverordnung (Hazardous Substances Ordinance) from 7.8.2000 Commission Directive 2001/58/EEC “Safety Data Sheets”
Chemikaliengesetz (Chemicals Act) amended 14.5.1998 Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to classification packaging and labelling of dangerous substances

Fundamental demands for workers´ protection are outlined in the Act on Workers´ Health Protection (corresponding to Directive 89/391/EEC) and Hazardous Substances Ordinance (corresponding to Directive 98/24/EEC):
• Risks resulting from work must be minimised
• Risks must be assessed and protective measures must be implemented
• Risk assessment and measures have to be documented
A general ranking for protective measures against chemical agents is also formulated:
• General and technical prevention is to be applied first
• Hazards are to be prevented at the source
• Personal protective measures are last choice

In Hazardous Substances Ordinance, which addresses dermal hazards explicitly, the hierarchy of measures is supplemented:
• substitution
• technical measures
• measures via changes in organisation
• personal protective equipment as last choice

Directive 98/24EEC addresses risk assessment and precautionary measures for handling chemical substances. Though the words “skin” or “dermal” do not occur in the directive, it is important for dermal risk management, because it gives a definition of “hazardous substance” that includes more substances than those that are formally classified. It creates a legal basis for protective measures for any chemical substance causing a risk in specific workplace scenarios (e.g. degreasing of skin, mechanical stress).

Personal protective equipment
Personal protective equipment, though ranking last in hierarchy, is important and frequently applied at workplaces. In the Ordinance on Use of PPE it is stated:
• The employer is legally responsible for selecting and providing PPE
• PPE must meet European standards
• PPE must be adequate and ergonomically acceptable
• Use of PPE must not cause a significant hazard
• Workers have to be instructed and trained on the use of PPE
• Skin barrier and skin care products are regarded as PPE

Substance specific information
Substance specific information is in principle available via Directive 67/548/EEC. It contains criteria for assigning dermal risk phrases to substances, describing skin damaging properties or a systemic hazard following dermal exposure. All substances must be classified. If a substance is not included in the official list of Annex I of this directive producers are obliged to classify on their own responsibility. Labelling and Safety Data Sheets (SDS) are established means to inform employers and represent a central instrument of communication. The new Directive 2001/58/EEC on SDS is far-reaching, since it allows to identify nearly a large number of hazardous ingredients in nearly all chemical products.

Technical rules
Technical rules (TRGS) have been developed on the basis of the Hazardous Substances Ordinance; they specify the requirements and support enforcement of the regulation. Some of these TRGS address dermal exposure explicitly:

TRGS 150
Direct dermal exposure to substances that may be absorbed through the skin (first ed.1989)
TRGS 530
Hairdressers (first ed. 1992)
TRGS 531
Wet work (first ed. 1996)
TRGS 540
Sensitising substances (first ed. 1996)
TRGS 710
Biomonitoring (first ed. 2000)
TRGS 900
Skin notations in the list of Occupational Exposure Limits (first ed. 1992)
TRGS 903
Limit values for biomonitoring (first ed. 2001)
TRGS 907
Inventory of sensitising substances (first ed. 1997)

TRGS 531 "Wet work"
Especially TRGS 531 “Wet work” should be regarded as innovative approach for skin protection. It is of considerable practical relevance, since many skin problems are caused by frequent exposure to water or prolonged work with protective gloves leading to a wet milieu within gloves.

Statutory accident insurance institutions
The statutory accident insurance institutions have their own responsibility for reducing risks at workplaces. In parallel to the 16 federal states that enforce national legislation there are 36 branch-specific and regionally based statutory accident insurance institutions which are commissioned to prevent and compensate occupational injuries and diseases. In accordance with the federal legal framework, they have their own set of rules and guidance, which may be very effective, because it is tailored to the specific needs of a certain branch. Examples for such rules are:

BGR 196 Chemical protective gloves
BGR 197 Use of skin care products
BGI 584 Skin cleaning, care and disinfection

Replacement of a skin damaging substance
Replacement of a skin damaging substance is the first choice of available measures. In Germany, the process of substitution has been started and maintained several times by discussions on new technical rules (TRGS) in the Hazardous Substances Committee with all affected parties. Discussions were often complemented by activities of the statutory accident insurances. Some campaigns have been successful in recent years:

•Latex allergies
Latex allergies developed into a significant problem, since the use of gloves became routine in the health care services. As most problems were associated with powdered gloves, these were restricted by the TRGS 540 in 1997. At the same time, the responsible statutory accident insurance ran a broad information campaign. As a result, in 2001 there were about 75% less suspected latex allergies compared to 1998.

•Hairdressers
Hairdressers have combined exposures to sensitising and irritating substances under wet work conditions. A bundle of precautionary measures including not only the elimination of known sensitising substances (esters of thioglycolic acid, nickel, latex, introducing products with reduced emission potential) but including also measures concerning the organisation (e.g., to reduce prolonged contact with water) and personal protection (use of gloves for certain work, skin care measures) were formulated in the TRGS 530 and mainly enforced by extensive campaigns of the responsible statutory accident insurance. As a result, the communications of suspected occupational skin diseases decreased from 4500 in 1991 to 1500 in 2001.

•Sensitisation to chromate
In Germany, about 400 cases of sensitisation to chromate (in cement) are confirmed every year in construction industries. Starting from a TRGS on the substitution of cements containing chromate, the German cement producing industry made a voluntary commitment to reduce chromate in cement during the mid-nineties. This approach has not been sufficiently effective. Therefore, Germany proposed on the EU-level to classify cements containing more than 0,2 ppm chromate as sensitising. This has been agreed and as a next step a proposal is under way to ban marketing and use of such cements at least for manual activities.

Hairdressers are also an encouraging example that it may be possible to restore health of persons with dermal diseases. By an integrated approach (secondary individual prevention) of seminars, training and risk assessment at workplaces, the incidence of severe skin problems could be reduced considerably.

Discussion items
Despite the existing legal framework, specific rules and campaigns, dermal diseases remained a main problem of workers´ health protection. In addition uncertainties about systemic effects after dermal exposure represent an important field of concern. The following items reflect actual discussions:

• Only existing toxicological information has to be used for classification and labelling, but many substances have not been tested sufficiently and exhibit data gaps.

• A quantitative risk characterisation is often connected with considerable uncertainties, because dermal exposure is difficult to assess in a quantitative sense. Actually, we are awaiting the results of a European project (RISKOFDERM) and have started national discussions on a respective Technical Rule.

• Skin permeation is a prerequesite of systemic effects after dermal contact. The scientific database to estimate the permeation rate is in many cases weak. Worst case assumptions are often used, which can weaken the reliability of a risk characterisation. Research projects are intended to be initiated and coordinated.

• Technical measures need to be systematically developed and endorsed. There are some strategies and examples of “good practice”, but there is no systematic technical guidance up to now. Research projects are intended to be initiated and coordinated.

• The use of gloves seemed a safe resort for risk management for a long time. However, many presumptions have been questioned during the last years.

- A list of sensitising substances in gloves has been established for the German market.

- It has also been questioned, whether the European Standards for glove testing are adequate (testing temperature, stretching of material) and whether permeation resistance can be sufficiently predicted from data bases that only contain rough information on the glove material. Several producers of chemical substances have begun to indicate in their SDS gloves, that have been tested especially for the specific product.

- There are current discussions whether it is possible to characterise workplace situations, in which contact with chemicals is a minor risk than prolonged wearing of protective gloves.

• It has become open to discussion how often protective creams keep their promises or whether they might even enhance the risks in certain cases.


Literature and links:

EU-legislation
Council Directive 89/391/EEC, Council Directive 98/24/EEC, Council Directive 89/656/EEC, Commission Directive 2001/58/EEC, Council Directive 67/548/EEC

German legislation
Arbeitsschutzgesetz, Gefahrstoffverordnung, PSA-Benutzungsverordnung, Chemikaliengesetz, TRGS 150, TRGS 530, TRGS 531, TRGS 540, TRGS 710, TRGS 900, TRGS 903, TRGS 907

Statistics of occupational diseases
http://www.hvbg.de/d/pages/infomat/wir/g-r/g-ergeb/bk/kap4.pdf

Statistics of occupational diseases
http://de.osha.eu.int/index.cfm?B8FCFBA9A7B442FB83AA36697A6B3D13

Statutory accident insurance institutions
http://www.hvbg.de/e/pages/index.htm

Neumeister, L., Hautschutz in der Textilindustrie, Der Sicherheitsschirm, 1/2002, S. 3-4

Elsner, P., Brandenburg, S., Rechtliche Grundlagen des Hautschutzes,Dermatol. Beruf Umwelt/Occup. Emnviron. Dermatol. 49 (2001), S. 54-58

Latex campaign
http://www.bgw-online.de/pressezentrum/pressearchiv/detail_presse.jsp?lfdDokNr=1035

Hairdressers campaign
http://www.bgw-online.de/pressezentrum/presseinformationen/detail_presse.jsp?lfdDokNr=1967

Sensitisers in gloves
http://www.gisbau.de/Allergen/Allergenliste.pdf

DIN EN 374 und Entwurf einer Neufassung prEN 374, Schutzhandschuhe gegen Chemikalien und Mikroorganismen, Berlin: Beuth 1994 und 1998

Oppl, R., Chemikalienschutzhandschuhe - Entwicklung, Erprobung und Dokumentation eines praxisgerechten und kostengünstigen Verfahrens zur Ermittlung der Durchlässigkeit (Permeation) von Schutzhandschuhen für gefährliche Zubereitungen, St. Augustin, Hauptverband der gewerblichen Berufsgenossenschaften (Hrsg.) 2000
http://www.hvbg.de/d/bia/pub/rep/rep01/forsch/handsch.pdf

Oppl R., Braun R., Schutzwirkungen von Schutzhandschuhen beim Umgang mit einer kaltverarbeiteten Bitumen-Emulsion, Schutzwirkungen von Schutzhandschuhen beim Umgang mit einer kaltverarbeiteten, lösemittelhaltigen Bitumen-Zubereitung - Prüfberichte. Hamburg: MILJÖ-CHEMIE 1999
www.deutsche-bauchemie.de/2verband/ausschus/fa4_bitu.htm

Hebisch, R. Rühl, R. : Hautkontakt mit Arbeits- und Gefahrstoffen- ein Diskussionspapier des AGS. ErgoMed 1/2002 S. 24-26

Gefährdungen durch dermale Exposition
http://www.baua.de/prax/ags/dermal.pdf

Aktueller Sachstand zur Branchenregelung „Chromatarme Zemente und Produkte“
http://www.cramif.fr/pdf/aiss/seance_poster/kluger.pdf

Chromatarme Zemente und zementhaltige Produkte
http://www.vdz-online.de/downloads/chr_arm/chr_arm.pdf

 

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