questionnaire 2 blvs · 2) does your member state currently have any binding blvs? ( ) yes ( ) no...

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Questionnaire 2 - BLVs 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 potential BLVs under the CMD. Separate questionnaires have been developed for a) OELVs, b) hexachlorobenzene, and c) Process Generated Substances (Diesel Engine Exhaust Emissions, Engine oils, Rubber process dust and fumes). These questionnaires are available here. The purpose of this questionnaire is to collect information and data in relation to the potential introduction of binding or guidance BLVs under the CMD, including on issues related to their use in practice, surveillance, and enforcement. 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

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Page 1: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

Questionnaire 2 - BLVs

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 potential BLVs under the CMD. Separate

questionnaires have been developed for a) OELVs, b) hexachlorobenzene, and c) Process

Generated Substances (Diesel Engine Exhaust Emissions, Engine oils, Rubber process dust

and fumes). These questionnaires are available here.

The purpose of this questionnaire is to collect information and data in relation to the potential

introduction of binding or guidance BLVs under the CMD, including on issues related to

their use in practice, surveillance, and enforcement.

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

Page 2: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

Background information

1) Please provide the following details

First name: _________________________________________________

Last name: _________________________________________________

Organisation: _________________________________________________

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

Page 3: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

( ) Slovenia

( ) Spain

( ) Sweden

( ) United Kingdom

( ) Other (please specify below)

Please specify the country in which your organisation is established:

_________________________________________________

Existing Biological Limit Values (BLVs)

2) Does your Member State currently have any binding BLVs?

( ) Yes

( ) No

3) If you answered YES to the previous question, please list the relevant

chemical agents, limit values, and media (e.g. urine, breath, blood, saliva, hair,

other). Alternatively, please provide a link to a document where these limits

can be found.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

4) Does your Member State currently have any non-binding (guidance) BLVs?

( ) Yes

( ) No

5) If you answered YES to the previous question, please list the relevant

chemical agents, limit values, and media (e.g. urine, breath, blood, saliva, hair,

Page 4: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

other). Alternatively, please provide a link to a document where these limits

can be found.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

Current arrangements for the implementation of binding

BLVs

6) Who is responsible for determining the sampling strategy (e.g. employers,

national authorities, etc.)? Please also provide information on how many

samples are taken and how often, and the specific arrangements for the

collection of samples.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

7) Are there requirements or recommendations for the minimum proportion

of workers that should be monitored?

____________________________________________

____________________________________________

____________________________________________

____________________________________________

Page 5: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

8) Who is responsible for collecting samples? Please differentiate between the different

media if required (e.g. urine: workers themselves, blood: qualified professional only).

Urine Breath Blood Saliva Hair Other

Workers

themselves

[ ] [ ] [ ] [ ] [ ] [ ]

Employer

using

internal staff

[ ] [ ] [ ] [ ] [ ] [ ]

Activity

outsourced

to

specialised

providers

(i.e qualified

professional)

[ ] [ ] [ ] [ ] [ ] [ ]

Public

authority

personnel

[ ] [ ] [ ] [ ] [ ] [ ]

9) Where are the samples collected?

Urine Breath Blood Saliva Hair Other

Only at

the

workplace

[ ] [ ] [ ] [ ] [ ] [ ]

Only

outside

the

workplace

(e.g. at a

healthcare

centre)

[ ] [ ] [ ] [ ] [ ] [ ]

Both at

the

[ ] [ ] [ ] [ ] [ ] [ ]

Page 6: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

workplace

and

elsewhere

10) Who is responsible for the storage and analysis of samples (e.g. employers,

third party providers, etc.)?

____________________________________________

____________________________________________

____________________________________________

____________________________________________

11) Who is responsible for the interpretation of the test results and decisions with

regard to the need for further risk mitigation?

[ ] A public authority

[ ] The employer

[ ] Another body (e.g. independent occupational hygiene specialists), please specify::

_________________________________________________

12) What is the format of the data that are used to formulate risk reduction measures?

[ ] Individual data – with worker’s name

[ ] Individual data - anonymised

[ ] Group data

[ ] Other - Write In: _________________________________________________

13) What situations trigger further risk reduction measures or a

recommendation to the employer to introduce further risk reduction

measures? For example, are there any requirements/guidance on how many

individual samples have to exceed the BLV and over what period they have to

have been taken?

____________________________________________

Page 7: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

____________________________________________

____________________________________________

____________________________________________

14) With regard to their contribution to worker health and safety, how would you rate

your experience with the existing binding BLVs?

( ) Highly positive

( ) Somewhat positive

( ) Neutral

( ) Somewhat negative

( ) Highly negative

( ) Other - Write In: _________________________________________________

15) With regard to their implementation (e.g. any problems encountered), how would

you rate your experience with the existing binding BLVs?

( ) Highly positive

( ) Somewhat positive

( ) Neutral

( ) Somewhat negative

( ) Highly negative

( ) Other - Write In: _________________________________________________

16) Does the employee have to give consent before.....

Yes No

a sample

is given?

( ) ( )

individual

test

results are

shared

( ) ( )

Page 8: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

with the

employer?

17) How often is employee consent sought?

( ) Every time a sample is taken

( ) Once in a certain period, please state period::

_________________________________________________

( ) No renewal, consent is valid until withdrawn

18) In what proportion of cases do workers typically refuse to provide consent

and to what extent does this limit the effectiveness of biomonitoring?

____________________________________________

____________________________________________

____________________________________________

____________________________________________

Current practices regarding the use of non-binding

(guidance) BLVs

19) In your Member State, is there a document recommending specific

arrangements for non-binding (guidance) BLVs?

Answer:

( ) Yes

( ) No

( ) Don't know

If yes, please provide a link to the document:

Page 9: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

____________________________________________

____________________________________________

____________________________________________

____________________________________________

20) Are there any recommendations on the minimum proportion of workers

to be monitored?

Answer:

( ) Yes

( ) No

( ) Don't know

If yes, please provide further details:

____________________________________________

____________________________________________

____________________________________________

____________________________________________

21) Are there any recommendations on the timing and frequency of sample

collection?

Answer:

( ) Yes

( ) No

( ) Don't know

If yes, please provide further details:

____________________________________________

____________________________________________

____________________________________________

____________________________________________

Page 10: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

22) Who is responsible for determining the sampling strategy (e.g. employers,

national authorities, etc.)?

If this is the employer, is there a public or professional body providing them

with advice?

Please also provide information on how many samples are taken and how

often, and the specific arrangements for the collection of samples.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

23) Who is allowed to collect samples? Please differentiate between the different media

if required (e.g. urine: workers themselves, blood: qualified professional only).

Urine Breath Blood Saliva Hair Other

Workers

themselves

[ ] [ ] [ ] [ ] [ ] [ ]

Employer

using

internal staff

[ ] [ ] [ ] [ ] [ ] [ ]

Activity

outsourced

to

specialised

providers

(i.e.

qualified

professional)

[ ] [ ] [ ] [ ] [ ] [ ]

Public

authority

personnel

[ ] [ ] [ ] [ ] [ ] [ ]

24) Where can samples be collected?

Page 11: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

Urine Breath Blood Saliva Hair Other

Only at

the

workplace

[ ] [ ] [ ] [ ] [ ] [ ]

Only

outside

the

workplace

(e.g. at a

healthcare

centre)

[ ] [ ] [ ] [ ] [ ] [ ]

Both at

the

workplace

and

elsewhere

[ ] [ ] [ ] [ ] [ ] [ ]

25) Are there any restrictions with regard to who can be involved in

the storage and analysis of samples (e.g. employers, third party providers

only, etc.)?

____________________________________________

____________________________________________

____________________________________________

____________________________________________

26) Who is responsible for the interpretation of the test results and decisions with

regard to the need for further risk mitigation?

[ ] A public authority

[ ] The employer

[ ] Another body (e.g. independent occupational hygiene specialists), please specify::

_________________________________________________

Page 12: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

27) What is the format of the data that are used to formulate risk reduction measures?

[ ] Individual data – with worker’s name

[ ] Individual data - anonymised

[ ] Group data

[ ] Other - Write In: _________________________________________________

28) Are there any rules/recommendations regarding the kind of situations that

should trigger further risk reduction measures or a recommendation to the

employer to introduce further risk reduction measures? For example, are

there any rules/recommendations on how many individual samples have to

exceed the BLV and over what period they have to have been taken?

____________________________________________

____________________________________________

____________________________________________

____________________________________________

29) With regard to their contribution to worker health and safety, how would you rate

your experience with the existing non-binding (guidance) BLVs?

( ) Highly positive

( ) Somewhat positive

( ) Neutral

( ) Somewhat negative

( ) Highly negative

( ) Other - Write In: _________________________________________________

30) With regard to their implementation (e.g. any problems encountered), how would

you rate your experience with the existing non-binding (guidance) BLVs?

( ) Highly positive

( ) Somewhat positive

( ) Neutral

( ) Somewhat negative

( ) Highly negative

Page 13: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

( ) Other - Write In: _________________________________________________

31) Does the employee have to give consent before.....

Yes No

a sample

is given?

( ) ( )

individual

test

results are

shared

with the

employer?

( ) ( )

32) Are there any rules/recommendations on how often is employee consent should

be sought?

( ) Every time a sample is taken

( ) Once in a certain period, please state period::

_________________________________________________

( ) No renewal, consent is valid until withdrawn

33) In what proportion of cases do workers typically refuse to provide consent

and to what extent does this limit the effectiveness of biomonitoring?

____________________________________________

____________________________________________

____________________________________________

____________________________________________

Potential new BLVs

Page 14: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

34) Feasibility of potential new binding BLVs

In your opinion, would it be feasible to implement binding BLVs for the above-

mentioned chemical agents? Please note that this relates to feasibility in general rather

than a specific limit value.

Yes No

MOCA ( ) ( )

Be and inorganic

Be compounds

( ) ( )

Hexachlorobenzene ( ) ( )

If you answered 'no' above, please elaborate in the box below.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

35) Does the feasibility of additional BLVs depend on the medium for

biomonitoring, i.e. urine, blood, saliva, hair, etc.?

____________________________________________

____________________________________________

____________________________________________

____________________________________________

36) Would the introduction of additional binding BLVs require changes to existing

legislation in your Member State?

( ) Significant changes

( ) Limited changes

( ) No changes

Page 15: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

37) Do you believe that additional binding BLVs have the potential to improve

occupational health?

Potential for

significant

improvement

Potential for

some

improvement

No

change

expected

Potential to

reduce

occupational

health

MOCA ( ) ( ) ( ) ( )

Be and inorganic

Be compounds

( ) ( ) ( ) ( )

Hexachlorobenzene ( ) ( ) ( ) ( )

38) Negative impacts of binding BLVs

Do you believe that the introduction of binding BLVs for any of the three chemical

agents would have any negative impacts on workers?

Yes No

MOCA ( ) ( )

Be and inorganic

Be compounds

( ) ( )

Hexachlorobenzene ( ) ( )

If you answered 'yes' above, please elaborate in the box below.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

39) Cost impacts of binding BLVs (public authorities)

Page 16: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

Do you believe that the introduction of binding BLVs for any of the three chemical

agents would have cost implications for public authorities in your Member State?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

Don't

know

MOCA ( ) ( ) ( ) ( ) ( ) ( )

Be and inorganic

Be compounds

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

Hexachlorobenzene ( ) ( ) ( ) ( ) ( ) ( )

Please provide more information in the box below.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

40) Cost impacts of binding BLVs (companies)

Do you believe that the introduction of binding BLVs for any of the three chemical

agents would have cost implications for companies in your Member State?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

Don't

know

MOCA ( ) ( ) ( ) ( ) ( ) ( )

Be and inorganic

Be compounds

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

Hexachlorobenzene ( ) ( ) ( ) ( ) ( ) ( )

Please provide more information in the box below.

____________________________________________

____________________________________________

Page 17: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

____________________________________________

____________________________________________

41) Feasibility of potential new non-binding (guidance) BLVs

In your opinion, would it be feasible to implement non-binding (guidance) BLVs for the

above-mentioned chemical agents? Please note that this relates to feasibility in general

rather than a specific limit value.

Yes No

MOCA ( ) ( )

Be and inorganic

Be compounds

( ) ( )

Hexachlorobenzene ( ) ( )

If you answered 'no' above, please elaborate in the box below.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

42) Does the feasibility of additional non-binding (guidance) BLVs depend on

the media for biomonitoring, i.e. urine, blood, saliva, hair, etc.?

____________________________________________

____________________________________________

____________________________________________

____________________________________________

43) Would the introduction of additional non-binding (guidance) BLVs require changes

to existing legislation in your Member State?

Page 18: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

( ) Significant changes

( ) Limited changes

( ) No changes

44) Do you believe that additional non-binding (guidance) BLVs have the potential to

improve occupational health?

Potential for

significant

improvement

Potential for

some

improvement

No

change

expected

Potential to

reduce

occupational

health

MOCA ( ) ( ) ( ) ( )

Be and inorganic

Be compounds

( ) ( ) ( ) ( )

Hexachlorobenzene ( ) ( ) ( ) ( )

45) Negative impacts of non-binding (guidance) BLVs

Do you believe that the introduction of non-binding (guidance) BLVs for any of the

three chemical agents would have any negative impacts on workers?

Yes No

MOCA ( ) ( )

Be and inorganic

Be compounds

( ) ( )

Hexachlorobenzene ( ) ( )

If you answered 'yes' above, please elaborate in the box below.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

Page 19: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

46) Cost impacts of non-binding (guidance) BLVs (public authorities)

Do you believe that the introduction of non-binding (guidance) BLVs for any of the

three chemical agents would have cost implications for public authorities in your

Member State?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

Don't

know

MOCA ( ) ( ) ( ) ( ) ( ) ( )

Be and inorganic

Be compounds

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

Hexachlorobenzene ( ) ( ) ( ) ( ) ( ) ( )

Please provide more information in the box below.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

47) Cost impacts of non-binding (guidance) BLVs (companies)

Do you believe that the introduction of non-binding (guidance) BLVs for any of the

three chemical agents would have cost implications for companies in your Member

State?

Significant

negative

impact

Moderate

negative

impact

No

impact

Moderate

positive

impact

Significant

positive

impact

Don't

know

MOCA ( ) ( ) ( ) ( ) ( ) ( )

Be and inorganic

Be compounds

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

Hexachlorobenzene ( ) ( ) ( ) ( ) ( ) ( )

Page 20: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

Please provide more information in the box below.

____________________________________________

____________________________________________

____________________________________________

____________________________________________

Other sources of information/further consultation

48) Are you aware of any guidance documents, evaluations, or other relevant

sources of information that would be useful for the assessment of the

feasibility of introducing additional BLVs? 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: _________________________________________________

Page 21: Questionnaire 2 BLVs · 2) Does your Member State currently have any binding BLVs? ( ) Yes ( ) No 3) If you answered YES to the previous question, please list the relevant chemical

Thank You!