Research

1
Research Science Chemfed 2nd Integration
Workshop 8th December 2004
2
The World of RS

• Building Public confidence that we know the risks
  inherent in our products especially to our
  children
• Intelligent ways of meeting the regulatory
  burden in an increasingly complex world
• Maintaining the innovative drive of the Chemicals
  Industry

3
Research Science

• Role of RS
• Underpinning sustained growth of a competitive
  Chemicals
• industry in Europe

• Addressing societal concerns about the impact of
  our operations and products within a risk based
  policy framework
• Generic research into health environmental
  impacts/ methodologies - Long-range Research
  Initiative LRI
• Childrens Health issue management CHE IMT

• Promoting a supportive environment for innovation
  
• Technology Platform for Sustainable Chemistries
  ETP-SC
• SUSTECH

RS Strategy Influence through Engagement and
constructive participation
4
RS Today the Issues we manage and the
Activities to support these

• Issues
• Childrens Health Environment - SCALE
• Innovation in Europe
• Endocrine Disruption
• Alternatives to animal testing
• Risk based Policy

• Programmes
• Long-range Research Initiative LRI
• Chemistry Technology Platform
• SUSTECH
• AllChemE Network

5
RS Organisation - Board and Chairmen
U-H. Felcht- Degussa J. Dopper- DSM N.
Sakkab- PG G. Clarizia- Polimeri E J. Rudolph-
Degussa T. Van S.Fiet- Dow
M. Droescher - Degussa
Prof. Tim Gant Leicester Univ
ECETOC
U. Jacobsson - ExxonMobil
G. Klotz - Bayer
Cefic Board Member Elected 26.11.04
6
RS Key Challenges 2005 -2006

• Funding LRI beyond 2005 how do we establish a
  sustainable rolling programme?
• Concerns about Children
• New understandings about development (genome)
• The politics of Bio-monitoring
• Creating a fertile environment for Chemicals
  innovation
• A slice of 34bn in the Framework 7 programme
• Representing the wider industry
• EU25
• Large and Small

7
Session Plan

• Overview of RS and Main Challenges
• Discussion Clarification of Issues
• Detail
• Context
• RS Approach
• LRI accomplishments and directions
• The Childrens Health and Environment Issue
• Innovation
• Debate
• How can RS help you?
• How can you help RS?

8
The world we operate in - 1

• Trust
• Knowing our products and their risks
• Distrust of us
• NGO driven fear of new technology
• Emotion based Policy SCALE
• Product Stewardship
• Increasingly complex regulation and testing
• Attacks on various product groups biomonitoring
• Attacks on Risk Assessment as a basis for
  regulation

9
The world we operate in - 2

• Competitiveness
• The importance of innovation for industry growth
• Falling/lower RD expenditure in Europe
• The regulatory burden on innovation
• Precautionary Principle led uncertainty for
  investment
• Legal/Policy
• Precautionary based policy
• Intellectual Property Costs in Europe
• Block Exemption policy - research consortia
• Environmental Liability

10
RS Response

• Sponsorship of independent and accredited
  research
• Being seen to do the right thing
• Combating junk science
• Effective Networking
• Pooling people and money
• Leverage of Commission Funding
• Access across the industry and with the
  authorities
• Engagement
• Influence/credibility with the authorities
• Defending/reinforcing risk assessment
• Early warning
• Stewardship of issues at their formative stage
• Reducing Uncertainty

11
LRI Principles

• Independent research
• Industry Level
• Managed through ECETOC (European Centre for
  Ecotoxicology and Toxicology of Chemicals) and
  ESAP (External Science Advisory Panel)
• Enable the engagement in emerging science issues
• Results owned by researchers
• Industry committed to act on results

12
LRI Phase 1 1996-2003

• History
• Origins in the Endocrine modulation issue in 1996
• LRI established as 5 year programme in 1998
  total commitments 25m (or 5m/annum) on 65
  projects
• Coordination at ICCA level
• Achievements
• Consensus Workshops defining Endocrine
  Disruption, use of QSAR in regulatory processes
• New understanding , chemicals in perspective
  thresholds in carcinogenesis, the health impacts
  of other causative factors
• Harmonised Validated Test methods OECD
• Reference Databases consumer exposures
• Models of the environmental fate of chemicals
• New lower cost, non animal testing methodologies
  QSAR programme with Commission/OECD

13
LRI Approach Bo Jansson
Basic research
Applied research
Exposure assessment
Effect assessment
Risk assessment
Risk management
14
LRI Projects B J

• Human Health Projects
•  Chemical Carcinogenesis (9)
•  Consumer Exposure (8)
•  Immunotoxicity and Allergy (1)
•  Respiratory Toxicity (6)
•  Tiered Risk Assessment (5)
•  Workplace Exposure (8)
• Environment Projects
• Environmental Modelling (8)
• Persistence, Bioaccumulation and Toxicity (6)
• Release and Uncertainty (2)
• Endocrine Disruption Projects
• Environment Wildlife (6)
• Male Reproductive Health (12)
• Testing Strategies and Risk Assessment (8)

15
Collating Disparate Data - BJ
Research inventory on indoor environment
(O) HEROX Workplace Exposure Research
(F) EXPOLIS-Index study (F) EXPOFACT European
exposure factors (O) Evaluation of existing
biomarkers of exposure (F) DB for workplace
exposure measurements (F) Emission databases in
Europe (F) DB for biomonitoring data (O)
16
Modelling Complexity - BJ
GEMCO estuary modelling system (F) Atmospheric
deposition model (F) TERRACE terrestrial runoff
model (F) CoZMo-POP coastal zone model for POPs
(O) GREAT-ER sediment exposure model
(O) Multi-media fate and transport models on
regional and global scale (F)
17
LRI Phase 2 2004 onwards

• New Directions
• Global planning of emerging issues through ICCA
• Building on Phase 1 achievements, adding
• Bio-monitoring as a tool to support risk
  assessment
• Environmental affects Childrens development
• New toxicology/eco-toxicology questions
  nanotechnology
• Intelligent testing Animal alternatives
• Population effects/ecological availability
• Frameworks for risk and precautionary decision
  making and communication

18
LRI Challenges

• Major Issue is funding (5m of 19m Cefic
  Horizontal budget)
• 2nd Phase Approved by Cefic Board October 2003
• Short term fix 2004/2005 is the Contingency fund
  (March 2004)
• Engaging the industry and institutions across
  EU25
• Global responses to issues such as Bio-Monitoring
• Revolutions in Science
• Analysis ahead of our ability to interpret
• Genomics

19
The Issue of Childrens Health
We have seen a trend in thinking which is now
integrated into policy considerations
To Hazard-based (Uncertainty/Precaution) Mixtures
/Low-dose Susceptible groups (children
elderly sick genetic variability) Emotion-based
policy
From Risk-based Single chemicals Species
variability Science-based policy
20
Evidence of Trend

• Policy
• IFCS from 1992 (WHO global programme focused on
  Childrens health)
• SAICM/UNEP
• CEHAPE, Budapest June 2004
• Calls for attention to chemicals including
  specific bans (Phthalates)
• SCALE Action Plan, June 2004

• Together with numerous other signals including
• The Endocrine Debate
• NGO Bio-monitoring campaigns
• Appel de Paris
• Lancet article Chemical Danger Lancet 10th
  July 2004

21
Childrens Health Issue Management

• Terms of reference
• ensure the Chemical industrys engagement in the
  European and International CHE-debate
• establish Chemical Industry as a credible
  partner in CHE-debates by contributing with its
  science programmes
• therefore coordinate CHE-advocacy /communication
  /science
• bring CHE-issues into other Chemical Programmes

22
CHE Progress - 1

• Full Involvement in SCALE
• Consultative Forum
• Technical Working Groups
• Broadening of original Chemicals focus
• All environmental factors
• Risk driven policy within June 2004 Action Plan
• Active advocacy on Mme Ries Parliament Report
• Extensive amendments tabled
• Cross party support
• Active involvement in Dutch Presidency Scale
  Conference
• Focus on Air Quality (indoor smoking), noise,
  building materials
• Research on other factors including chemicals
• Industry representation on conference round table

23
CHE Progress - 2

• Industry representation on European Environment
  Health Committee
• Provided direct industry input to the agreements
  in Budapest 2004 (WHO CEHAPE)
• Active coordination through ICCA Technical
  Affairs Group
• Direct input into WHO IFCS UNEP SAICM

24
CHE Challenges

• Communicating industry positions in face of
  emotion children, body burden
• Responding to the rapid advances of science in
  development/ genomics
• Maintaining focus on Risk despite the
  uncertainties
• Maintaining Political focus on Environmental
  priorities across EU25

25
Stimulating European Innovation

• SUSTECH Programme (started 1994)
• Facilitation (no funding) of 10 industry/academia
  consortia in sustainable development
• Process modelling
• Hydrogen energy
• Catalysis
• Industrially contaminated land recovery
• Human factors in process industries
• Solids processing
• Separation technology
• Multi-scale approaches to processing
• Biotechnology
• Nanotechnology
• HYNET is now a technology Platform for the
  development of a hydrogen economy
• NICOLE (reclamation of industrially contaminated
  land) role in ETAP
• New consortia on process intensification and
  catalysis recently awarded funding under
  Framework Programme 6

26
AllChemE
                     
The Industry
      
Chairmen of European Chemistry Research Councils
       
ESF European Cooperation in the field of
Science and Technology, Technical Committee on
Chemistry
European Associations for Chemistry and
Molecular Sciences
      
              
European Federation for Chemical Engineering
Chemistry Education Thematic Network
27
European Technology Platform for Sustainable
Chemistry

• Major industry initiative to provide industry
  vision to shape part of Commission Framework
  research funding (FP7 totals 35bn/4yr)
• Multi-stakeholder activity in public/private
  partnership creating fertile science industry
  interaction
• Establish in 2005 for the 2007 funding round

28
Technology Platforms

• June 2004 Commission publishes
• FP7 outline (COM (2004) 353) ETP discussion
  document
• ETPs are 1 of 6 priorities for FP7, and are
• a framework to unite stakeholders around
• Industry led
• a common vision and approach for the industry/
  technology concerned
• definition of a Strategic Research Agenda (SRA)
• An implementation plan for the SRA, mobilisation
  of a critical mass of research and innovation
  effort
• European Technology Platform for Sustainable
  Chemistry is 1 of some 20 initiatives

29
Industry Drivers

• Innovation is a key driver for the growth and
  competitiveness of the Chemicals industry in
  Europe www.cefic.org/horizon2015
• Innovation in the Chemicals industry is key to
  innovation in other industrial sectors
• The industry is keen to promote an innovation
  supportive environment for chemistry in Europe
• This requires multi-stakeholder involvement and
  collaborative chemistry RD
• FP7, aligning EU national RD initiatives
• supporting policy developments
• Relevant to large and small companies
• Working through AllChemE

30
Technology Platform History
Nov 02 Commr Busquin introduces Technology
platform concept to Cefic RS delegation Nov
03 Cefic and Commission agree on initiating
the European Technology Platform for
Sustainable Chemistry Jan 04 COM (2004) 101
FP7 to double funds and include ETPs ERC
(ETP-SC mentioned as an example) June 04
Cefic/EuropaBio release ETP-SC document 6
July 2004 Commr Busquin launches ETP-SC
http//www.ceficsustech.org/files/Publications/ETP
_sustainable_chemistry.pdf
31
The Technology PlatformSustainable Chemistry

• Platform Deliverables
• Stakeholder engagement
• Multi-stakeholder vision for chemistry (Q1 05)
• A common chemistry RD strategy in priority
  technology areas (Q4 05)
• Action Plan for strategy implementation incl.
  mobilization of public private resources (Q4
  05)
• Scope
• Four working groups
• Industrial (or white) biotechnology new routes
  and products
• Materials technology including nantechnology
• Reaction and Process Design process
  intensification
• Horizontal issues
• Research infrastructure
• Barriers and constraints to innovation including
  Health Environment
• Member states mirror group

32
The Technology PlatformSustainable Chemistry
Advisory Council
Member States Mirror Group
Platform Secretariat
Horizontal Issues Working Group
Industrial Bio-technology
Materials Tech-nology
Reaction Process Design
33
ETP-SC envisioned timing
34
Overall Conclusions

• RS is working at European Level and linked
  Globally through ICCA
• It is engaged
• Through active independent research
• Participation in the political process (CHE,
  Endocrine, Animal Alternatives, Innovation
• Through leadership of the Technology Platform
• It is well Networked
• Through LRI Funding
• Through AllchemE
• Through Participation

35
Helping You?

• European Perspectives on Environment and Health
  (EH) and Innovation
• Experience in the debates relating to EH and
  Innovation
• Ability to bring relevant technical expertise
• Forums for discussion of European Policy in
  Innovation and EH

36
Helping us?

• Reaching the wider industry
• Addressing specific questions in the Accession
  Countries
• Burden of Environment on Health
• All MEPs are equal
• Effective advocacy at Parliament and Council level

37
Importance of Risk Based Policy
Risk function Hazard (toxicology) x exposure
(Dose, timing)

• Principles
• Objectivity with regards safety
• Priority setting
• Judging alternatives

38
Importance of Risk Based Policy
Even when things are uncertain you have to make a
best judgement of risk

• Industry position on precaution
• sound science evaluation
• actions proportional to the perceived risk
• careful examination of the costs and benefits
  of
• action or inaction
• a well understood process for re-evaluating
• decisions when new information becomes
• available