5.  Exclude people & organisations with conflicts of interest from decision making.  

Intensive lobbying by scientists working in the public health interest to implement changes to assessment policy are ignored.  The information is there - independent science says the current models are not flexible enough and don't test at the full formulation at the levels we are exposed to. But the agencies don't respond. Why?

In all agencies, it is the pesticide industry (as the applicant/notifier/sponsor) that is handed responsibility for selecting and supplying studies used in regulatory assessment, reviews and reregistrations - the very industry that is dependent on a favourable outcome.

The current situation:

(a) Europe Commission, the RMS & EFSA

How Europe works - Regulation (EC) No 1107/2009 concerns the placing of plant protection products on the market.

'The evaluation of both existing and new active substances is done through a phased approach:

1.       For each substance an initial draft risk assessment report (DAR) is produced by a designated rapporteur Member State (RMS),

2.       The RMS’s risk assessment is peer reviewed by EFSA in cooperation with all Member States,

3.       EFSA drafts a conclusion on the active substance,

4.       The European Commission takes a legislative decision whether or not to include the substance in the Union’s list of approved active substances.'  [1]

 Since 2009 mandatory reviews of independent literature are required. The pesticide industry must submit the literature review to the RMS. A 2014 paper titled 'Missed & Dismissed' that reviewed 7 pesticides assessments, noted industry 'decided to qualify none of them as reliable enough to use in determining risk. As always, they took advantage of the EFSA Guidance to use Klimisch to dismiss without analysis these and thousands more studies (some of which would be useful, though we did not look at them) on these seven pesticides alone. This means industry and regulators have not even read these studies and so cannot assess their quality…but do so anyway.' [2]

The European risk assessment of glyphosate has long been the subject of controversy. Non-industry scientists concluded that in regards to the 2002 glyphosate (Roundup) assessment, the RMS 'cherry picked' studies to suit a lower toxicity status, and dismissed poisonings from chronic tests without thorough investigation. Consultation was on outdated studies and without reference to independent research which revealed many of the older studies to be discredited or outdated.

Independent scientists considered that the Rapporteur Member State had previously downplayed findings of 'serious harm in industry studies on glyphosate. It irresponsibly proposed a high “safe” exposure level for the public that ignored important data on glyphosate’s teratogenic effects'.  [3]  However this continues - the current European Renewal Assessment Report (RAR) for glyphosate excludes many relevant studies and has been found to be 'preliminary and inconclusive.' [4]

The author of the current European glyphosate Renewal Assessment Report (RAR) is unknown - it is considered to be the consortium of chemical companies who form the Glyphosate Task Force. While the German Federal Institute for Risk Assessment (BfR-- Bundesinstitut für Risikobewertung) is responsible for the report, no confirmation has been advised of who authored it. [5] Much of the report has accepted without question, private industry studies - while refusing to admit published, peer reviewed studies, citing narrow guidelines and dismissing all published studies that researched the full formulation. Industry's influence in manipulating the risk assessment process is unquestionable.

The UK Guardian newspaper commented: 'We do not know if the BfR evaluation is unusual in having been drafted by the firms whose products were being evaluated, or unusual because German regulators were honest enough to make that practice explicit. But if one of the world’s wealthiest nations does not have sufficient resources to conduct its own independent evaluations of toxicological evidence we might well ask what are the practices in regulatory institutions elsewhere?' [6]

Independent science based Corporate Europe Observatory (CEO) and Earth Open Source in 2012 documented the conflicts of interest within with the European Food Safety Authority in it's paper 'Conflicts on the Menu: A decade of industry influence at the European Food Safety Authority (EFSA).

A further paper by CEO in 2013 confirmed that 'more than half of experts at the EU food safety authority have conflicts of interest'.

The PAN Europe report Poisonous Injection: How industry tries to water down the risk assessment of pesticide mixtures in everyday food outlined:

'a well planned and orchestrated attempt of industry to undermine policies meant to evaluate the toxicity of chemicals mixtures (cumulative risk assessment, CRA). This is done by putting industry-linked experts in crucial positions in expert panels of the World Health Organisation (WHO) and of the European Food Safety Authority EFSA. A massive delay in policy implementation is the result. Eight years after the EU mandated such risk assessments for pesticide residues in food, EFSA still fails to carry them out, leaving consumers and citizens unprotected against the harms of mixtures of pesticides in food.'

(b) World Health Organisation and the Food & Agriculture Organisation (FAO).

The existing WHO/FAO pesticide toxicity assessment system is managed by the JMPR (Joint Meeting on Pesticide Residues).  The JMPR works intimately with pesticides organisations who directly provide the (private) science.  The JMPR is an expert ad hoc body administered jointly by the FAO and WHO with the purpose of ‘harmonizing the requirement and the risk assessment on the pesticide residues’. Panel members of the JMPR, in theory, act individually and do not represent governments.

The JMPR evaluates and recommends to the Codex Committee on Pesticide Residues (CCPR), to establish Codex Alimentarius maximum residue limits. The Codex pesticide residue limits are then instituted by member countries (including New Zealand).

While the JMPR sounds great at first glance, only directly supplied corporate studies make up the core studies that act to establish the ADI/ARfD’s that identify the safe daily levels of pesticides the world population is permitted to be exposed to on a daily basis. JMPR is made up of people deeply entrenched in the existing status quo of pesticide regulation, in which the industry supplies the data and has a close, cosy relationship with the regulators.

The WHO/FAO system is tightly managed, with the registrant only supplying the core studies, as with the US EPA and Europe’s EFSA. There may be an open ‘call for data’, but when you review the final Toxicological Evaluations it is corporate studies that supply the core decisions. 

In all UN chemicals processes, regulatory decisions, and the industry data on which they are based, are always given the most credibility.

There is no international financing system, nor parameters inviting independent, public domain scientists to supply, for example, the long term carcinogenicity studies that provide the important ‘backbone’ of research that confirms the safety of the chemical concerned.

(c) US Environmental Protection Agency & the FDA

The FDA approved the use of genetically modified organisms. This directly impacts on pesticide approvals as the major percentage of GMO's carry the Roundup Ready gene - and therefore carry higher pesticide residues.  Michael Taylor, a former Monsanto employee and the now Deputy Commissioner for the US FDA was responsible for establishing the policy that GM food would be GRAS, Generally Regarded as Safe. This had the result of GM foods not requiring safety tests or labelling. [4]

The US EPA approves pesticides. However the studies are supplied by the pesticide corporations. There appears to be no drive, no commitment to demanding independent research. 

So whilst EPA scientists may exhibit integrity, EPA policy reveals deep conflicts of interest that may stem from decisions made by senior management.

How can a government Agency representing 314 million people exclude independent research when making public health decisions?

It's not RITE.

 

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References:

[1] European Food Safety Authority - online content: 'Pesticides Peer Review'.

[2] Missed & Dismisssed: Pesticide Regulators Ignore the legal obligation to use independent science for deriving safe exposure levels. Pesticide Action Network Europe and Generation Futures. September 2014.

[3] Download the report – Roundup and birth defects: Is the public being kept in the dark?

[4] Testbiotech comment on the German Renewal Assessment Report (RAR) on the active ingredient glyphosate. Andreas Bauer-Panskus, October 2014

[5] The Glyphosate Saga, & “independent scientific advice” according to Germany, the UK & France. Corporate Europe Observatory.

[6]Chemical reactions: glyphosate and the politics of chemical safety. May 2015 The Guardian. Patrick van Zwanenberg   

[7] GMO Myths and Truths - Earth Open Source. M. Antoniou, C. Robinson, J.Fagan. June 2012

[8] Weighing Safety Of Weed Killer In Drinking Water, EPA Relies Heavily On Industry-Backed Studies. D.Ivory. 2010 Huffington Post Investigative Fund.

[9] A Poisonous Injection: How industry tries to water down the risk assessment of pesticide mixtures in everyday food. PAN Europe. Hans Muilerman, René Houkema. 2014