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Erschienen in: NanoEthics 1/2013

01.04.2013 | Original Paper

Discovering Specific Conditions for Compliance with Soft Regulation Related to Work with Nanomaterials

Erschienen in: NanoEthics | Ausgabe 1/2013

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Abstract

At workplaces where nanomaterials are produced or used, risk assessment and risk management are extremely difficult tasks since there is still limited evidence about the risks of nanomaterials. Measurement methods for nanoparticles are contested and safety standards have not yet been developed properly. To support compliance with the legal obligation of the employer to care for safe workplaces a large number of ‘soft’ regulatory tools have been proposed (e.g. codes of conduct, benchmarks, standards). However, it is not clear whether and under which conditions soft regulation is complied with. This article discusses the potential advantages and drawbacks of soft regulation. It explores compliance issues when exposure measurement devices and other technology-related factors are involved. The exploration of three examples of soft regulation on occupational health and safety (a ministerial recommendation on preliminary exposure benchmarks, a nano-specific guidance of a chemical company and a public–private OHS guideline) shows that the capacity of the regulated parties to comply depends on the availability of appropriate technological devices and methods, technical expertise and other resources. When technological prerequisites are met, compliance is likely to increase.

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Fußnoten
1
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work; Council Directive 98/24/EC of 7 April on the protection of the health and safety of workers from the risks related to chemical agents at work; and Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.
 
2
Council Directive 89/391/EEC, section ll, article 9(1).
 
3
Directive 98/24/EC; and Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
 
4
See, for instance, Articles 3 and 5 Dutch Labour Conditions Act; Articles 3–6 German Occupational Health and Safety Act and the Laws on hazardous substances.
 
5
Directive 98/24/EC; and REACH Regulation (EC) No 1907/2006.
 
6
Various scientists even claim that definite answers on the risks of nanomaterials might be years away, only emerging on a case-by-case basis (e.g. [67, p. 4343]).
 
7
See note 2. By ‘regulation’ we understand sustainable rules of conduct which serve to achieve certain policy goals, and which are based on certain (private or public) regulatory authority. Regulation refers to the activities of standard-setting, implementation, monitoring and enforcement [21, p. 156; 57, p. 60].
 
8
Examples of private ‘soft’ regulation are: codes of conduct, guidelines of private organizations etc. Public regulators are also competent to set non-legally binding regulations. Examples are: recommendations, communications and guidelines.
 
9
Since soft regulation is prominent in risk assessment and risk management the focus lies on soft OHS instruments. The compliance conditions that are discussed in the next section generally apply to soft and hard regulation.
 
10
These examples of soft regulation were selected because compliance relies on different technical devices and because they cover a variety of regulators (public, private and public/private). The Dutch Recommendation on Nano Reference Values is an interesting example of soft regulation because the NRVs are part of a current discussion of international relevance on the topic of exposure values for working with nanomaterials (e.g. by the British Standards Institute [16] or the German Institute for Occupational Safety and Health of the German Social Accident Insurance [8]). The BASF guideline is particular interesting because BASF is a worldwide leading company in the chemical industry, which is involved in various private and public projects on the safety of nanomaterials. The Baua and VCI Guidance for Handling and Use of Nanomaterials at the Workplace [9] is very informative. It is co-regulated with the German Chemical Industry Association.
 
11
Ministry of Social Affairs and Employment, Letter from 10 August 2010 (G&VW/GW/2010/14925).
 
12
The NRVs have been developed by analogy with other substances such as asbestos or fine-dust particles and they are considered benchmarks, that is ‘warning levels’. They are a provisional alternative for health-based recommended occupational exposure limits (HBR-OELs) or derived no-effect levels (DNELs), based on a precautionary approach. When these levels are exceeded measures are required to identify the source and if possible minimize exposure [19, p. 17].
 
13
The first principle refers to the manufacture of new products containing nanoscale materials of enhanced properties, the second principle deals with identifying potential environmental and health risks of nanotechnologies. The third principle addresses the future usage of nanotechnology by BASF and, lastly, the company commits to engage in open dialogue with society related to activities with nanotechnology. For details concerning the four principles of the BASF Code [6].
 
14
This sum was mentioned in the interviews that were held in the Dutch Pilot NRV (see, [17]).
 
15
The same critique has been made on the NanoTracer [62, p. 62].
 
16
British Standard on a Guide to safe handling and disposal of manufactured nanomaterials [16].
 
17
The BASF guideline which advocates the GRIMM SMPS + C’s detection system relies on this method.
 
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Metadaten
Titel
Discovering Specific Conditions for Compliance with Soft Regulation Related to Work with Nanomaterials
Publikationsdatum
01.04.2013
Erschienen in
NanoEthics / Ausgabe 1/2013
Print ISSN: 1871-4757
Elektronische ISSN: 1871-4765
DOI
https://doi.org/10.1007/s11569-013-0165-7

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