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

Material & Energy Flows - Laws/Targets? – Eco-efficiency, Green chemistry?

I m p a c t s

Public HealthOccupational Health

Environmental and Ecological Health

Damage from Respiratory, Cardiovascular, Neurological, Reproductive, Developmental, Carcinogenic, Physical agents.

Pollution of Damage to

Air Water Soil Ecosystems

Atmosphere

c. 500 Health & Environmental LawsWith more to come as Knowledge of Impacts expands

Source: EEA 2006

Dykes

Fingers

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• Review of monitoring 04-06 (Unpublished)• Chapter in SOER 05• DG Article in Special issue EHP on EDS 06• Co-organised Weybridge +10 conference on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

• Beyond all reasonable doubt (scientific 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 animal

+ - +

Positive aninal, negative human,

plausible risk

+ + +

Positve animal & human, plausible

risk

1996

ACGIH

1996

HSIA,

Online, Industry

1996

OECD/EU

UK, Int.Org.

1995

IARC

Int. org

1996

Deutche

Forschungsgemeinschaft,

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

1 Some features can go either way (e.g.inapproriate controls) but most of the features mainly err in the direction shown in the table

SCIENTIFIC STUDIES

SOME METHODOLOGICAL FEATURES

MAIN1 DIRECTIONS OF ERROR-INCREASES CHANCES OF DETECTING A:

Experimental •High doses •False positive*

Studies •Short (in biological terms) range of doses

•False negative

(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)

EEA draft

Observational •Confounders •False positive/negative*

Studies •Inappropriate controls •False positive/negative

(Wildlife & •Non-differential exposure misclassification

•False negative

Humans) •Inadequate follow-up •False negative

•Lost cases •False negative

•Simple models that do not reflect complexity

•False negative

Both •Publication bias towards positives •False positive

Experimental

And

•Scientific cultural pressure to avoid false positives

•False negative

Observational

Studies

•Low statistical power (e.g. From small studies)

•False negative

•Use of 5 % probability level to minimise chances of false positives

•Funding bias

•False negative

•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 Table 16

“Uncertain” or “uncertainty”

 

In concluding section

In concluding section

Anywhere in 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 with

Strong

Associated with Moderate

Little evidence that* Weak

Unlikely to be*

Very Weak

*refer to evidence baseAs 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 with

Probable

Associated with Possible

Unlikely to be Unlikely

Little evidence that Very unlikely

Very little evidence that

Extremely unlikely