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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
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
( ) 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,
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?
____________________________________________
____________________________________________
____________________________________________
____________________________________________
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
[ ] [ ] [ ] [ ] [ ] [ ]
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?
____________________________________________
____________________________________________
____________________________________________
____________________________________________
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
( ) ( )
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:
____________________________________________
____________________________________________
____________________________________________
____________________________________________
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:
____________________________________________
____________________________________________
____________________________________________
____________________________________________
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?
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::
_________________________________________________
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
( ) 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
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
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)
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.
____________________________________________
____________________________________________
____________________________________________
____________________________________________
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?
( ) 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.
____________________________________________
____________________________________________
____________________________________________
____________________________________________
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 ( ) ( ) ( ) ( ) ( ) ( )
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: _________________________________________________
Thank You!