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Meta-analysis of interviews with experts, policy makers and stakeholders current opinions and perceptions, ideas on policy options and future directions. Dries Coertjens UAntwerp Semi-structured interviews with key respondents Per


  1. Meta-analysis of interviews with experts, policy makers and stakeholders current opinions and perceptions, ideas on policy options and future directions. Dries Coertjens UAntwerp

  2. Semi-structured interviews with key respondents Per erspectiv ives Number of of interv rvie iews/ interv rvie iewees Ex Experts on phthalates and bisphenols from the consortium 4/6 EU po EU polic licy mak akers ( DG’s and agencies) 6/8 Ind Industry ry 3/9 NGO’s 3/3 16/ 16/27 Main objective of the interviews:  Map perspectives on the topic as a preparatory step for a dialogue at the workshop * A meta-analysis of these interviews will be reported as part of a deliverable on the case study on phthalates and bisphenols (due in February ‘19) – respondents will have the opportunity to provide their feedback on the draft report. 2

  3. Three main topics discussed in interviews A. The current sci scientific evid vidence bas ase on phthalates and bisphenols. B. B. Chall allenges an and ob obstacles for policy making on phthalates and bisphenols, and the (potential) role of HBM(4EU). C. The relevance of different poli olicy in instruments and good practic ices (at EU and national level). 3

  4. Main conclusions from interviews A. On the evidence base…*  Both substance groups have been studied for many years… This makes it ‘old’, but prototypical cas ases.  Phthalates: there appears to be a growing scientific and societal consensus. Best illustrated by the current restriction proposal for four phthalates.  Willingness to discuss challenges and obstacles for implementation of the restriction by most respondents, as well as the potential relevance of other (supporting) policy instruments.  Debate on bisphenols (BPA) seems to remain more controversial.  Less willingness to discuss policy options by some respondents, except large-scale research (e.g. Clarity studies in US, HBM4EU?) * Statements in these slides are only based on a meta-analysis of the interviews (= perceptions, opinions), not on a scientific evaluation. 4

  5. Main conclusions from interviews Phthalates: often heard arguments/milestones  In Innovatio ion: HBM-data (DEMOCOPHES) used in HIA as a basis for the restriction proposal for four phthalates, taking into account com ombin ined effects of exposure to these four phthalates. (Approx. 5% of children in EU at risk, in 2011) o “The history of the phthalates case illustrates the importance of good quality data to support regulatory policy making.”  Nevertheless: the scientific methodology for assessing the combined effects is still much debated. ➔ "Making better use of HBM-data could be (part of) the solution”  While others argue that it is all too little, too slow. (“only 4 of the 10 phthalates on the SVHC list included”; “FCM excluded”; etc.) 5

  6. Main conclusions from interviews Bisphenols: often heard arguments/milestones  Persistent controversy, fuelled by the disc discrepancy between: o standardised reg egulatory ry stu tudie ies (used for formal risk assessments) that do not report health effects, o and an increasing number of academic stu tudie ies reporting effects (but lacking reproducibility – therefore not meeting the quality standards for regulatory risk assessment).  A large-scale study in the US (Cla larit ity) aims to bridge this discrepancy, but has not yet been able to bridge the controversy.  BPA was added to the SVH VHC list and its use in the thermal l pap paper (e.g. cash receipts) will be banned from 2020 onwards.  EFSA’s risk assessment for BPA in foo ood and and FCM has been revised in 2015 (introducing considerably lower TDI’s) but still concludes that there is no health risk from BPA from food intake at current exposure levels. 6

  7. Main conclusions from interviews  However, the controversy does not so much relate to the specific substances, but rather to the ‘wider context’: o “The slo slow pr process ss of substance-by- substance assessments.” o “The lac lack of of kno nowledge on mixtures and cumulative exposure.” o “The fragm gmented management (in the different policy silos) and implementation gaps.” o “Divergent judgements on how to deal w ith un uncertainties and the need for pr precautio ionary po poli licy initiatives.” o “The lack of tr transparency .”  Nevertheless, the phthalates and bisphenols cases are found to be good cases to track progress in this respect (prototypes).  And HBM is judged to be an important ‘ trigger ’ for innovation: o ‘To show real eal lif life/ e/actual l expos osures ’ o ‘To triggering a more ho holi listic app pproach ’ 7

  8. Main conclusions from interviews B. Challenges for policy making and the role of HBM(4EU) – topics for debate: I. I. How to o de deal with th HBM da data in n ris risk ass assessment t and and reg egula latio ion? (‘ How to reconcile a holistic approach with compartmentalised policy making?’)  “Do the procedures have to be adjusted? (make use of HBM compulsory, define quality requirements, develop routines )”  “Will good quality data find its way automatically?”  “Should joint reflection across policy domains be organised more frequently/more structurally?”  “Do we have to identify policy opportunities more actively?” o [ What difference will it make for risk management? ] o [ Which role for HBM4EU? ] 8

  9. Main conclusions from interviews B. Challenges for policy making and the role of HBM(4EU) – topics for debate: II. II. How to o com ommunicate on on ph phth thala lates and and bisp bisphenols ls in n a a con ontext xt of of unc uncert rtainty ty?  Communication on HBM data – by scientists  Communication as a policy instrument, e.g. for awareness raising. – by policy makers  Communication to build trust in EU, science, the market, … – as a collective endeavour o [ Citizens right to be informed + Citizens expectation to be informed by governments (as a trusted information source). ] o [ Importance of nuanced communication, not causing unnecessary fear or ‘ chemophobia ’ ] o [ Joint reflection on main messages recommended ] 9

  10. Main conclusions from interviews B. Challenges for policy making and the role of HBM(4EU) – topics for debate: III. III. How can HBM(4 (4EU) he help lp to o bui build ld trus trust of of ci citiz izens in n the the reg egula latory ry system? (as well as trust in science, EU industry, the market, …) IV. Can an HBM da data he help lp to o pri priori ritise atten entio ion? (Most problematic substances? Or also vulnerable/high exposed groups or profiles?) V. V. Wha hat ot other r pol polic icy ins nstruments ts/actio ions gai ain leg egit itim imacy by the the HBM- evi vidence on on ph phth thala lates and and bisp bisphenols? o Phthalates: all instruments that can support the phasing out of restricted phthalates? o Bisphenols: minimally monitoring and informing the public? 10

  11. Main conclusions from interviews C. Identified policy instruments and good practices Informing, Monito- awareness ring raising Authorisa Promoting tion & alternat- ives restriction Enforce- ment Labelling Education Strategy Partner- develop- ship ment Economic instru- ments 11

  12. How can HBM4EU support policy making? II. How to communicate on I. How to deal with HBM phthalates and bisphenols (in data in risk assessment a context of uncertainty) and regulation Informing, awareness Monitoring raising Promoting Authorisation & restriction alternatives V. Which actions Enforcement gain legitimacy by Labelling Education HBM-evidence? Towards a Non-toxic Partnership environment Economic instruments III. Can HBM4EU help to IV. Can HBM data be build trust of citizens in used to prioritise EU, science, market, … our attention? 12

  13. Contacts ilse.loots@uantwerpen.be ann.crabbe@uantwerpen.be dries.coertjens@uantwerpen.be This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 733032.

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