questionnaire 1 - oelvsquestionnaire 1 - oelvs introduction rpa ltd (united kingdom), together with...

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Questionnaire 1 - OELVs Introduction RPA Ltd (United Kingdom), together with FoBiG (Germany), Triskelion (the Netherlands), Milieu (Belgium), and EPRD (Poland) have been contracted by the European Commission (DG Employment, Social Affairs and Inclusion) to support the evaluation of a possible amendment of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (hereinafter referred to as the CMD). Please note that this study is different to the RPA’s recent study that related to the European Commission’s proposal to establish new or revised OELVs for a priority list of 13 chemical agents[1] published in May 2016. The objective of this study is to assess the impacts of some of the potential changes to the CMD, which could include, amongst others, the establishment of Occupational Exposure Limit Values (OELVs) for trichloroethylene, 1,2-dichloroethane, beryllium and inorganic beryllium compounds, 1,2- dibromoethane, 1-chloro-2,3-epoxypropane, and 4,4’- methylenedianiline (MDA), and Biological Limit Values (BLVs) for beryllium and inorganic beryllium compounds and 4,4’- methylene-bis(2-chloroaniline) (MOCA). In addition, the study evaluates the extent of exposure to hexachlorobenzene and the impacts of a potential inclusion of some Process Generated Substances (PGSs) into Annex 1 of the CMD. The subject of this questionnaire are the potential OELVs for the chemical agents listed in the table below. Separate questionnaires have been developed for a) Biological Limit Values (BLVs), b) hexachlorobenzene, and c) Process Generated Substances (Diesel Engine Exhaust Emissions, Engine oils, Rubber process dust and fumes). These questionnaires are available here. Chemical agent CAS number OELV under consideration (8 hr TWA) Trichloroethylene 79-01-6 10 ppm 1,2-dichloroethane 107-06-2 8.14 mg/m 3 (2 ppm) 1,2-dibromoethane 106-93-4 0.8 mg/m 3 (0.1 ppm) 1-chloro-2,3-epoxypropane (epichlorohydrine) 106-89-8 1.9 mg/m 3 1,4’-methylenedianiline (MDA) 101-77-9 80 μg/m 3 Beryllium and inorganic beryllium compounds - Four policy options: A: 2 μg/m 3 B: 0.6 μg/m 3 C: 0.2 μg/m 3 D: 0.02 μg/m 3 (All options expressed as inhalable fraction) The purpose of the consultation exercise is to collect data and information feeding into the assessment of the potential impacts of the measures under consideration and, in particular, the evaluation of potential impacts on competitiveness and SMEs.

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Questionnaire 1 - OELVs

Introduction

RPA Ltd (United Kingdom), together with FoBiG (Germany), Triskelion (the Netherlands),

Milieu (Belgium), and EPRD (Poland) have been contracted by the European Commission

(DG Employment, Social Affairs and Inclusion) to support the evaluation of a possible

amendment of Directive 2004/37/EC on the protection of workers from the risks related to

exposure to carcinogens or mutagens at work (hereinafter referred to as the CMD).

Please note that this study is different to the RPA’s recent study that related to the European

Commission’s proposal to establish new or revised OELVs for a priority list of 13 chemical

agents[1] published in May 2016.

The objective of this study is to assess the impacts of some of the potential changes to the

CMD, which could include, amongst others, the establishment of Occupational Exposure

Limit Values (OELVs) for trichloroethylene, 1,2-dichloroethane, beryllium and inorganic

beryllium compounds, 1,2- dibromoethane, 1-chloro-2,3-epoxypropane, and 4,4’-

methylenedianiline (MDA), and Biological Limit Values (BLVs) for beryllium and inorganic

beryllium compounds and 4,4’- methylene-bis(2-chloroaniline) (MOCA). In addition, the

study evaluates the extent of exposure to hexachlorobenzene and the impacts of a potential

inclusion of some Process Generated Substances (PGSs) into Annex 1 of the CMD.

The subject of this questionnaire are the potential OELVs for the chemical agents listed

in the table below. Separate questionnaires have been developed for a) Biological Limit

Values (BLVs), b) hexachlorobenzene, and c) Process Generated Substances (Diesel Engine

Exhaust Emissions, Engine oils, Rubber process dust and fumes). These questionnaires are

available here.

Chemical agent CAS number OELV under consideration

(8 hr TWA)

Trichloroethylene 79-01-6 10 ppm

1,2-dichloroethane 107-06-2 8.14 mg/m3 (2

ppm)

1,2-dibromoethane 106-93-4 0.8 mg/m3 (0.1 ppm)

1-chloro-2,3-epoxypropane (epichlorohydrine) 106-89-8 1.9 mg/m3

1,4’-methylenedianiline (MDA) 101-77-9 80 μg/m3

Beryllium and inorganic beryllium compounds -

Four policy options:

A: 2 μg/m3

B: 0.6 μg/m3

C: 0.2 μg/m3

D: 0.02 μg/m3

(All options expressed as

inhalable fraction)

The purpose of the consultation exercise is to collect data and information feeding into the

assessment of the potential impacts of the measures under consideration and, in particular, the

evaluation of potential impacts on competitiveness and SMEs.

Responses to this questionnaire will be handled in the strictest confidence and will only be

used for the purposes of this study. In preparing our reports for the Commission (which,

subsequently, may be published), care will be taken to ensure that specific responses

cannot be linked to individual companies. If you have specific concerns about how your

views will be treated, you can contact us and we will be happy to discuss your concerns.

The deadline for completion of the questionnaire is 26th October 2016 . If you have any

questions about this survey or the study more generally, please contact Daniel Vencovsky

([email protected] or +44 (0)1508 528 465).

[1] See http://europa.eu/rapid/press-release_MEMO-16-1655_en.htm and

https://ec.europa.eu/transparency/regdoc/rep/1/2016/EN/1-2016-248-EN-F1-1.PDF

Background information

1) Please provide the following details

First name: _________________________________________________

Last name: _________________________________________________

Company: _________________________________________________

Email address: _________________________________________________

Telephone number: _________________________________________________

In which country is your organisation based?

( ) Austria

( ) Belgium

( ) Bulgaria

( ) Croatia

( ) Cyprus

( ) Czech Republic

( ) Denmark

( ) Estonia

( ) Finland

( ) France

( ) Germany

( ) Greece

( ) Hungary

( ) Ireland

( ) Italy

( ) Latvia

( ) Lithuania

( ) Luxembourg

( ) Malta

( ) Netherlands

( ) Poland

( ) Portugal

( ) Romania

( ) Slovakia

( ) Slovenia

( ) Spain

( ) Sweden

( ) United Kingdom

( ) Other

Please specify the country in which your organisation is established:

_________________________________________________

2) What size is your company? For enterprise size definitions, please refer to

the following link: http://ec.europa.eu/growth/smes/business-friendly-environment/sme-

definition/index_en.htm

( ) Micro enterprise (less than 10 persons employed)

( ) Small enterprise (10-49 persons employed)

( ) Medium-sized enterprise (50-249 persons employed)

( ) Large enterprise (250 or more persons employed)

Relevant chemical agents

3) Which of the following chemical agents does your company produce or use? For the

purposes of this questionnaire, the term 'use' refers to any activity during

which occupational exposure to the relevant chemical agent may occur.

Production Use

Trichloroethylene

(CAS No. 79-01-

6)

[ ] [ ]

1,2-dichloroethane

(CAS No. 107-06-

2)

[ ] [ ]

1,2-dibromoethane

(CAS No. 106-93-

4)

[ ] [ ]

1-chloro-2,3-

epoxypropane

(epichlorohydrine)

(CAS No. 106-89-

8)

[ ] [ ]

1,4’-

methylenedianiline

(MDA) (CAS No.

101-77-9)

[ ] [ ]

Beryllium and/or

inorganic

beryllium

compounds

[ ] [ ]

Trichloroethylene (CAS No. 79-01-6)

4) How many people at your company are occupationally exposed to trichloroethylene

and at what concentration?

Number of workers exposed:: _________________________________________________

Concentration (please specify unit)::

_________________________________________________

Duration and frequency of exposure (please specify unit)::

_________________________________________________

Please describe the activity/process during which exposure occurs::

_________________________________________________

5) What would be the likely impact on your company of reducing exposure to a level

below the OELV under consideration (trichloroethylene: 1ppm 8 hour TWA)?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

One off costs

(investment)

( ) ( ) ( ) ( ) ( )

Operating costs ( ) ( ) ( ) ( ) ( )

Level playing

field in the

internal market

( ) ( ) ( ) ( ) ( )

Occupational

health & safety

( ) ( ) ( ) ( ) ( )

Competitiveness

vis-à-vis third

countries

( ) ( ) ( ) ( ) ( )

Staff wellbeing

and comfort

( ) ( ) ( ) ( ) ( )

6) Please provide further details about the likely impacts:

____________________________________________

____________________________________________

____________________________________________

____________________________________________

7) What measures would your company have to implement to meet the OELV

under consideration (trichloroethylene: 1ppm 8 hour TWA)? This could

include, for example, additional Personal Protective Equipment, changes to

the production process, etc.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

8) Please estimate the cost (in €) of the measures identified in your response to the

previous question.

One-off (investment) cost (in €):

_________________________________________________

Additional operating costs (€ per year):

_________________________________________________

1,2-dichloroethane (CAS No. 107-06-2)

9) How many people at your company are occupationally exposed to 1,2-dichloroethane

and at what concentration?

Number of workers exposed:: _________________________________________________

Concentration (please specify unit)::

_________________________________________________

Duration and frequency of exposure (please specify unit)::

_________________________________________________

Please describe the activity/process during which exposure occurs::

_________________________________________________

10) What would be the likely impact on your company of reducing exposure to a level

below the OELV under consideration (1,2-dichloroethane: 8.14 mg/m3 8-hr TWA/2

ppm 8-hr TWA)?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

One off costs

(investment)

( ) ( ) ( ) ( ) ( )

Operating costs ( ) ( ) ( ) ( ) ( )

Level playing

field in the

internal market

( ) ( ) ( ) ( ) ( )

Occupational

health & safety

( ) ( ) ( ) ( ) ( )

Competitiveness

vis-à-vis third

countries

( ) ( ) ( ) ( ) ( )

Staff wellbeing

and comfort

( ) ( ) ( ) ( ) ( )

11) Please provide further details about the likely impacts:

____________________________________________

____________________________________________

____________________________________________

____________________________________________

12) What measures would your company have to implement to meet the

OELV under consideration (1,2-dichloroethane: 8.14 mg/m3 8-ht TWA/2 ppm

8-hr TWA)? This could include, for example, additional Personal Protective

Equipment, changes to the production process, etc.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

13) Please estimate the cost (in €) of the measures identified in your response to the

previous question.

One-off (investment) cost (in €):

_________________________________________________

Additional operating costs (€ per year):

_________________________________________________

1,2-dibromoethane (CAS No. 106-93-4)

14) How many people at your company are occupationally exposed to 1,2-

dibromoethane (CAS No. 106-93-4) and at what concentration?

Number of workers exposed:: _________________________________________________

Concentration (please specify unit)::

_________________________________________________

Duration and frequency of exposure (please specify unit)::

_________________________________________________

Please describe the activity/process during which exposure occurs::

_________________________________________________

15) What would be the likely impact on your company of reducing exposure to a level

below the OELV under consideration (1,2-dibromoethane: 0.8 mg/m3 8-hr TWA/0.1

ppm 8-hr TWA)?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

Staff

wellbeing

and

comfort

One off costs

(investment)

( ) ( ) ( ) ( ) ( ) ( )

Operating costs ( ) ( ) ( ) ( ) ( ) ( )

Level playing

field in the

internal market

( ) ( ) ( ) ( ) ( ) ( )

Occupational

health & safety

( ) ( ) ( ) ( ) ( ) ( )

Competitiveness

vis-à-vis third

countries

( ) ( ) ( ) ( ) ( ) ( )

16) Please provide further details about the likely impacts:

____________________________________________

____________________________________________

____________________________________________

____________________________________________

17) What measures would your company have to implement to meet the

OELV under consideration (1,2-dibromoethane: 0.8 mg/m3 8-hr TWA/0.1

ppm 8-hr TWA)? This could include, for example, additional Personal

Protective Equipment, changes to the production process, etc.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

18) Please estimate the cost (in €) of the measures identified in your response to the

previous question.

One-off (investment) cost (in €):

_________________________________________________

Additional operating costs (€ per year):

_________________________________________________

1-chloro-2,3-epoxypropane (epichlorohydrine) (CAS No

106-89-8)

19) How many people at your company are occupationally exposed to 1-chloro-2,3-

epoxypropane (epichlorohydrine) (CAS No 106-89-8) and at what concentration?

Number of workers exposed:: _________________________________________________

Concentration (please specify unit)::

_________________________________________________

Duration and frequency of exposure (please specify unit)::

_________________________________________________

Please describe the activity/process during which exposure occurs::

_________________________________________________

20) What would be the likely impact on your company of reducing exposure to a level

below the OELV under consideration (epichlorohydrine: 1.9 mg/m3 8-hr TWA)?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

One off costs

(investment)

( ) ( ) ( ) ( ) ( )

Operating costs ( ) ( ) ( ) ( ) ( )

Level playing

field in the

internal market

( ) ( ) ( ) ( ) ( )

Occupational

health & safety

( ) ( ) ( ) ( ) ( )

Competitiveness

vis-à-vis third

countries

( ) ( ) ( ) ( ) ( )

Staff wellbeing

and comfort

( ) ( ) ( ) ( ) ( )

21) Please provide further details about the likely impacts:

____________________________________________

____________________________________________

____________________________________________

____________________________________________

22) What measures would your company have to implement to meet the

OELV under consideration (epichlorohydrine: 1.9 mg/m3 8-hr TWA)? This

could include, for example, additional Personal Protective

Equipment, changes to the production process, etc.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

23) Please estimate the cost (in €) of the measures identified in your response to the

previous question.

One-off (investment) cost (in €):

_________________________________________________

Additional operating costs (€ per year):

_________________________________________________

1,4’-methylenedianiline (MDA) (CAS No. 101-77-9)

24) How many people at your company are occupationally exposed to 1,4’-

methylenedianiline (MDA) (CAS No. 101-77-9) and at what concentration?

Number of workers exposed:: _________________________________________________

Concentration (please specify unit)::

_________________________________________________

Duration and frequency of exposure (please specify unit)::

_________________________________________________

Please describe the activity/process during which exposure occurs::

_________________________________________________

25) What would be the likely impact on your company of reducing exposure to a level

below the OELV under consideration (MDA: 80 μg/m3 TWA)?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

One off costs

(investment)

( ) ( ) ( ) ( ) ( )

Operating costs ( ) ( ) ( ) ( ) ( )

Level playing

field in the

internal market

( ) ( ) ( ) ( ) ( )

Occupational

health & safety

( ) ( ) ( ) ( ) ( )

Competitiveness

vis-à-vis third

countries

( ) ( ) ( ) ( ) ( )

Staff wellbeing

and comfort

( ) ( ) ( ) ( ) ( )

26) Please provide further details about the likely impacts:

____________________________________________

____________________________________________

____________________________________________

____________________________________________

27) What measures would your company have to implement to meet the

OELV under consideration (MDA: 80 μg/m3 TWA)? This could include, for

example, additional Personal Protective Equipment, changes to the

production process, etc.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

28) Please estimate the cost (in €) of the measures identified in your response to the

previous question.

One-off (investment) cost (in €):

_________________________________________________

Additional operating costs (€ per year):

_________________________________________________

Beryllium and inorganic beryllium compounds

29) Does your company use and/or produce beryllium or inorganic beryllium

compounds?

[ ] We use beryllium

[ ] We produce beryllium

[ ] We use inorganic beryllium compounds

[ ] We produce inorganic beryllium compounds

30) If you use and/or produce inorganic beryllium compounds, please tell us

which ones?

_________________________________________________

31) How many people at your company are occupationally exposed to beryllium and/or

inorganic beryllium compounds and at what concentration(s)?

Number of workers exposed:: _________________________________________________

Concentration (please specify unit)::

_________________________________________________

Duration and frequency of exposure (please specify unit)::

_________________________________________________

Please describe the activity/process during which exposure occurs::

_________________________________________________

Policy Option A: 2 μg/m3 8-hr TWA (inhalable fraction)

32) What would be the likely impact on your company of reducing exposure to a level

below the OELV considered under Option A (Be and inorganic Be compounds: 2 μg/m3

8-hr TWA inhalable fraction)?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

One off costs

(investment)

( ) ( ) ( ) ( ) ( )

Operating costs ( ) ( ) ( ) ( ) ( )

Level playing

field in the

internal market

( ) ( ) ( ) ( ) ( )

Occupational

health & safety

( ) ( ) ( ) ( ) ( )

Competitiveness

vis-à-vis third

countries

( ) ( ) ( ) ( ) ( )

Staff wellbeing

and comfort

( ) ( ) ( ) ( ) ( )

33) Please provide further details about the likely impacts:

____________________________________________

____________________________________________

____________________________________________

____________________________________________

34) What measures would your company have to implement to meet the

OELV considered under Option A (Be and inorganic Be compounds: 2 μg/m3

8-hr TWA inhalable fraction)? This could include, for example, additional

Personal Protective Equipment, changes to the production process, etc.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

35) Please estimate the cost (in €) of the measures identified in your response to the

previous question.

One-off (investment) cost (in €):

_________________________________________________

Additional operating costs (€ per year):

_________________________________________________

Policy Option B: 0.6 μg/m3 8-hr TWA (inhalable fraction)

36) What would be the likely impact on your company of reducing exposure to a level

below the OELV considered under Option B (Be and inorganic Be compounds: 0.6

μg/m3 8-hr TWA inhalable fraction)?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

One off costs

(investment)

( ) ( ) ( ) ( ) ( )

Operating costs ( ) ( ) ( ) ( ) ( )

Level playing

field in the

internal market

( ) ( ) ( ) ( ) ( )

Occupational

health & safety

( ) ( ) ( ) ( ) ( )

Competitiveness

vis-à-vis third

countries

( ) ( ) ( ) ( ) ( )

Staff wellbeing

and comfort

( ) ( ) ( ) ( ) ( )

37) Please provide further details about the likely impacts:

____________________________________________

____________________________________________

____________________________________________

____________________________________________

38) What measures would your company have to implement to meet the

OELV considered under Option B (Be and inorganic Be compounds: 0.6

μg/m3 8-hr TWA inhalable fraction)? This could include, for example,

additional Personal Protective Equipment, changes to the production process,

etc.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

39) Please estimate the cost (in €) of the measures identified in your response to the

previous question.

One-off (investment) cost (in €):

_________________________________________________

Additional operating costs (€ per year):

_________________________________________________

Policy Option C: 0.2 μg/m3 8-hr TWA (inhalable fraction)

40) What would be the likely impact on your company of reducing exposure to a level

below the OELV considered under Option C (Be and inorganic Be compounds: 0.2

μg/m3 8-hr TWA inhalable fraction)?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

One off costs

(investment)

( ) ( ) ( ) ( ) ( )

Operating costs ( ) ( ) ( ) ( ) ( )

Level playing

field in the

internal market

( ) ( ) ( ) ( ) ( )

Occupational

health & safety

( ) ( ) ( ) ( ) ( )

Competitiveness

vis-à-vis third

countries

( ) ( ) ( ) ( ) ( )

Staff wellbeing

and comfort

( ) ( ) ( ) ( ) ( )

41) Please provide further details about the likely impacts:

____________________________________________

____________________________________________

____________________________________________

____________________________________________

42) What measures would your company have to implement to meet the

OELV considered under Option C (Be and inorganic Be compounds: 0.2

μg/m3 8-hr TWA inhalable fraction)? This could include, for example,

additional Personal Protective Equipment, changes to the production process,

etc.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

43) Please estimate the cost (in €) of the measures identified in your response to the

previous question.

One-off (investment) cost (in €):

_________________________________________________

Additional operating costs (€ per year):

_________________________________________________

Policy Option D: 0.02 μg/m3 8-hr TWA (inhalable

fraction)

44) What would be the likely impact on your company of reducing exposure to a level

below the OELV considered under Option D (Be and inorganic Be compounds: 0.02

μg/m3 8-hr TWA inhalable fraction)?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

One off costs

(investment)

( ) ( ) ( ) ( ) ( )

Operating costs ( ) ( ) ( ) ( ) ( )

Level playing

field in the

internal market

( ) ( ) ( ) ( ) ( )

Occupational

health & safety

( ) ( ) ( ) ( ) ( )

Competitiveness

vis-à-vis third

countries

( ) ( ) ( ) ( ) ( )

Staff wellbeing ( ) ( ) ( ) ( ) ( )

and comfort

45) Please provide further details about the likely impacts:

____________________________________________

____________________________________________

____________________________________________

____________________________________________

46) What measures would your company have to implement to meet the

OELV considered under Option D (Be and inorganic Be compounds: 0.02

μg/m3 8-hr TWA inhalable fraction)? This could include, for example,

additional Personal Protective Equipment, changes to the production process,

etc.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

47) Please estimate the cost (in €) of the measures identified in your response to the

previous question.

One-off (investment) cost (in €):

_________________________________________________

Additional operating costs (€ per year):

_________________________________________________

Other sources of information/further consultation

48) Are you aware of any position papers, evaluations, or other relevant

sources of information that would be useful for estimating the extent of

exposure to the relevant chemical agents and assessing the impacts of the

OELVs under consideration? If so, please specify how the consultants could

gain access to such studies (Internet links, author name and affiliation, etc.).

____________________________________________

____________________________________________

____________________________________________

____________________________________________

49) Would you be willing to take part in a follow up telephone interview?

( ) Yes

( ) No

50) If yes, please provide your contact details (if you have not already done

so):

Name: _________________________________________________

Email Address: _________________________________________________

Phone Number: _________________________________________________

Thank You!