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Chemicals & the EEA
Chemicals in Water Workshop
Dec. 2010
Ecological & Health Impacts
of Economic Activities:
“Better Dykes or More Fingers?”
Human Needs
Use of Resources and Energy
Dykes Material & Energy Flows - Laws/Targets? – Eco-
efficiency, Green chemistry?
I m p a c t s
Occupational Public Health Environmental and Ecological
Health Health
Damage from Respiratory, Cardiovascular, Pollution of Damage to
Neurological, Reproductive,
Developmental, Carcinogenic, Physical Air Water Soil Ecosystems
Fingers agents.
Atmosphere
c. 500 Health & Environmental Laws
With more to come as Knowledge of Impacts expands
Source: EEA 2006
Summary
• Activities on Chemicals at EEA 98-10
• Prenatal Programming of Harm
• Towards Transparency in Evaluating
Evidence.
• On Biases.
“Chemicals in Europe :Low Doses
,High Stakes?” (EEA/UNEP 98/9)
• 100k chemicals on market
• “Less than 25 %” of HPVCs have enough tox.
data for minimal OECD RA; (14% ECB 99 & 06)
• Would Take 100s years to RA them at current
rate
• Little incentive for Chem Co’s to do Tox studies-
burden of proof on States.
• Mixtures very important-largely ignored
• As are externalities; the PP; substitutes, green
chemistry..
risk assessment/management is
extremely slow…
•500 + EDCs are known
• 20 have been assessed in respect to their
endocrine disrupting properties
• 10 have been internationally regulated
(9 POPs + TBT)
(German UBA, 08)
Why Children are “Vulnerable,
Valuable and at Risk”(EEA 99)
• Greater scientific complexity, uncertainty and ignorance (nescience
) about children’s health
• Generally more sensitive to harmful agents
• longer to live: harm has longer time to impact on today’s children
• Much harm from chemicals etc today will only impact on tomorrow’s
children
• benefit inequity: children get fewer benefits from sources of harm, such
as jobs, car driving, many consumer products
• lack of power: involuntary harm yet children have least power to avoid
it.
Chemicals at EEA 01-10
• Benzene, TBT, PCBs, CFCs, MTBE, DES, Gt
Lakes pollution, Antibiotics/animal feed/beef
hormones in “Late Lessons from Early
Warnings” 01
• Review of monitoring 04-06 (Unpublished)
• Chapter in SOER 05
• DG Article in Special issue EHP on EDS 06
• Co-organised Weybridge +10 conference on
EDS, 07: updated proceedings 11
Other EEA Activities…
• Co-organised Faroes conference & Statement
on Repro/Developmental Hazards+ Proceedings
08,
• Pharmaceuticals in the Environment Report ‘10
• Ecotox workshop 10+ Chems in Water report ‘11
• Lead ,Mercury, Gaucho, Booster, Biocides,
PERC chapters in “Late Lessons” v 2, ‘11
• Update “Low Doses” as part of REACH review
‘12?
Pharmaceuticals in the
Environment ‘10
• “situation looks worse” than 99 Early
Warning
• little data on exposures fate ,impacts.
• Mixtures, bio acumulation,persistence.
• Need life cycle approach; green
pharmacy; better environmental RA, WW
treatment, take back schemes, & info to
clinicians/public
EU Parliament on Pharma. in
Environment
• (5a)The pollution of waters and soils with certain
pharmaceutical residues is an emerging environmental
problem. Member States should consider measures to
monitor and evaluate the risk of environmental effects of
such medicinal products, including those which may
have an impact on public health.
• The Commission should, based inter alia on data
received from the Agency, the Environment Agency,
and Member States, produce a report on the scale of
the problem, along with an assessment on whether
amendments to EU legislation on medicinal products or
other relevant EU legislation are required.
The Prenatal Programming of
Dysfunction and Disease?
• In utero exposures to nutritional/chemical
agents seem to cause pre-natal, natal,
adolescent, adult, and trans-generational
dysfunctions and diseases…..
• Behaviour, IQ, Alzheimers, Parkinsons,
Cancer, Reproductive Effects, Heart
Disease, Obesity, Diabetes,
Immunotoxicity.
Some Prenatal Programming
Stressors?
• DES, TBT, DTT/E, PCBs, Dioxins,
BPA, vinyl acetate, phthalates,
• vinclozolin, atrazine, paraquat/maneb,
• PMs, PAHs,lead, manganese,
methylmercury, arsenic,
• aspartame, under/over nutrition,
smoking, alcohol, stress,…..
Other Relevant Activities
• Bradford Hill 40th anniversary mtg 05 (with Imperial
College)
• “Towards Transparency in Evaluating Evidence”
workshop for SANCO network of Chairs of EU RA
Committees 08:
• 4 pairs of case studies where RA committees got
opposite evaluations of same evidence, inc. BPA &
Pesticides spray drift.
• Checklist on reasons for divergent evaluations in “Late
Lessons” v 2
• PP conference 10 years after EU Communication, ’10
Bradford Hill on different
Strengths of Evidence 1965
• “relatively slight evidence” for pregnancy pill ban
• “fair evidence” for reduced/eliminated exposure to
probable carcinogenic oil at work
• “Very strong evidence” for public restrictions on
smoking or diets.
Bradford Hill, The Environment & Disease: Association or
Causation?”, Proc Roy. Soc Med ,1965, 58, 295-300.
Some Strengths of Scientific
•
Evidence (scientific
Beyond all reasonable doubt
causality & criminal law)
• Reasonable certainty (IPCC, 2007)
• Balance of probabilities/evidence
(IPCC,2001)
• Strong possibility (IARC on ELF 2002)
• Scientific suspicion of risk (Swedish
Chemicals Law)
• “Pertinent information” (WTO SPS justifying
Country actions to protect health
Different Conclusions: “Same Knowledge”
Evaluated?
Classification of TCE risk assessment reports in 1995/6 (from Ruden
2002)
-- - +-- +-+ +++
negative Positive Positive aninal, Positve animal &
negative human, human, plausible
animal plausible risk risk
1996 1996 1996 1995
ACGIH HSIA, OECD/EU IARC
Online, UK, Int.Org. Int. org
Industry
1996
Deutche
Forschungsgem
einschaft,
DFG, germany
1996
MAK
Gerrmany Occ.
agency
Transparency in Evaluating
Evidence-EEA Workshop 08
• Institutional: Q asked; membership
• Knowledges accepted for review
• Weights given to knowledges
• Treatment of Biases & Uncertainties
• Rules by which knowledges assessed become evidence
asserted-”perils of the precis”
• Rules for establishing Confidences;
Understandings,Likelihoods about cause/effect links; and
• for conclusions about Strengths of Evidence (for different
purposes)
• Clear & Consistent terminology needed.
On Biases..
• Methodological,
• Funding
• Intellectual
ON BEING WRONG: Environmental Health
Sciences and Their Directions of Error
SCIENTIFIC SOME METHODOLOGICAL MAIN1 DIRECTIONS OF
STUDIES FEATURES ERROR-INCREASES
CHANCES OF DETECTING A:
Experimental •High doses •False positive*
Studies •Short (in biological terms) range •False negative
of doses
(Animal) •Low genetic variability •False negative
•Few exposures to mixtures •False negative
•Few Foetal-lifetime exposures •False negative
•High fertility strains •False negative
(Developmental/reproductive
endpoints)
1Some features can go either way (e.g.inapproriate controls) but
most of the features mainly err in the direction shown in the table
EEA draft
Observational •Confounders •False positive/negative*
Studies •Inappropriate controls •False positive/negative
(Wildlife & •Non-differential exposure •False negative
misclassification
Humans) •Inadequate follow-up •False negative
•Lost cases •False negative
•Simple models that do not reflect •False negative
complexity
Both •Publication bias towards positives •False positive
Experimental •Scientific cultural pressure to avoid •False negative
And false positives
Observational •Low statistical power (e.g. From •False negative
Studies small studies)
•Use of 5 % probability level to •False negative
minimise chances of false positives
•Funding bias •False negative
(Gee, Bailar, Grandjean,2004,
updated Gee 2008.)
Main Direction of Error is False
Negative..
• 2 False Positives; 3 either way; 12/13 False
Negatives.
• (but weighting of each needed?)
• Produces conservative science but often unsafe
public policy
• Decisionmakers need to be aware of this
imbalance..
• Could there be a better balance between
FPs/FNs for Environmental Health sciences?
Funding Biases..
• See the Vatican and its seeking of
scientists who would contradict Galileo.
(“Rivals”, M. White)
• See histories of Asbestos, Lead, Pharma,
Tobacco, BPA, & Mobile phones
where source of funding strongly
influences nature of the results
Intellectual Bias in the Beef
Hormones case at WTO…..2008.
“The European Communities alleges that the Panel disregarded
its "most important objection "that Drs. Boisseau and Boobis,
who participated in the drafting of JECFA reports, could
not be independent and impartial because they were
asked to evaluate the risk assessments that were "very
critical of the JECFA reports".
Source: p27, para 65 World Trade Organization, WT/DS320/AB/R, “United States-Continued
Suspension of Obligations in the EC-Hormones Dispute”, (16 October 2008)
Qualitative expression of
uncertainty
Committee Any term from “Uncertain” or “uncertainty”
Table 16
In concluding In concluding Anywhere in
section section opinion
SCCNFP 20% 0% 5%
SCCP 52% 0% 29%
SCENIHR 80% 80% 80%
SCHER 63% 26% 53%
SCMPMD 73% 18% 55%
SCTEE 83% 38% 79%
Some current causal terminology..
• ”Effects mostly obscure”
• ”Seems to be linked to”
• ”Tempting to suggest that”
• ”Have been shown to
contribute to”
• ”Might be associated with”
• ”Substantially contributed to”
Towards more transparent & consistent terminology?
For cause/effect link Strength of Evidence
Causally linked to Very Strong
Strongly associated Strong
with
Associated with Moderate
Little evidence that* Weak
Unlikely to be* Very Weak
*refer to evidence base
As no evidence of harm
is not evidence of no
harm
Towards more transparent & consistent terminology?
Terminology Strength of Evidence
Known to Extremely likely
Causally linked to Very likely
Strongly associated Probable
with
Associated with Possible
Unlikely to be Unlikely
Little evidence that Very unlikely
Very little evidence that Extremely unlikely
