The high, protective wall of the agrichemical industry: and the bricks are made of GLP.

crcason (1)You want irony?  Currently the 3 major organisations in the world that are meant to represent people and prescribe safe levels of chemicals on food – the FAO/WHO, EPA and the European Union, constantly reject new science that shows current pesticide and herbicide residues are too high on the food we eat .

These rejections are based on two little  loopholes, enmeshed in our laws and regulations that have nothing to do with risk assessment, or toxicological safety… unless you are a pesticide organisation.

1. GLP – Good Laboratory Practice

2. OECD Test Guideline toxicity test methods

I like to think of it more as a big wall of corporate protectionism across all these countries, than loopholes.

How many people do WHO/FAO, the USA and the EU represent?  Billions.

Across the world we have scientists with peer reviewed, publicly funded research (Ie. not funded by agrichemical companies) demonstrating repeatedly that chemicals such as glyphosate are being applied to our food in increasingly toxic quantities to the human.  And this science is being ignored.

In Europe this loophole is called the Kimlisch loophole (Kimlisch was an employee of the huge chemical giant BASF), and Klimisch and his colleagues cleverly established that there is only one criterion for the most reliable studies: Was it done according to Good Laboratory Practice (GLP)?  [1]

GLP in its present form put together by the USDA and since then the OECD has promoted it and developed it alongside ‘Test Guidelines’ and helped get it in lots of country’s regulations. Please note the OECD is all about development and trade, and NOT science.

Good Laboratory Practice has nothing to do with rigorous scientific testing for toxicity of chemicals.

In fact it is only ever the registrant (the chemical company) that is asked for studies in the first place.  Never public domain science – independent science.  And when independent scientists try to provide studies, they are rejected often because they do not use this protocal: ‘Good Laboratory Practice’, a narrow, tick the box industry approved data quality system.  A laboratory management system.  To prevent fraud.  A system that hitches its wagon to an OECD test guideline system that has nothing to do with identifying sensitive results for safe risk assessment, that public domain science often finds.

“This criterion effectively excludes most independent (non-industry sponsored) studies from consideration, since only industry studies are done according to GLP. GLP is not a hallmark of good or reliable science: it is a laboratory management system invented for the purpose of preventing fraud in industry studies conducted for regulatory purposes. Researchers operating independently of industry consider GLP to be irrelevant to their research – and thus too expensive in terms of labour hours to implement without good reason. Crucially, at no point have regulators informed independent scientists that their study is considered unreliable for not using GLP.”[2]

And for many scientists working in the public sector results happen all over the place, but GLP doesn’t really allow for that to happen.  So public sector scientists don’t use it. They want true results.  And the results from scientific studies can be messy, difficult to comprehend, and inconsistent.

And right now, industry, in collusion with the EPA, WHO/FAO and the EU, is debunking excellent peer reviewed literature that says current chemical residue levels of glyphosate are toxic to humans and animals, massively and consistently, whilst hiding their own scientific studies (that support higher doses of pesticide residues) as ‘unpublished documents’ away from peer review by independent scientists.

Right now, the first ever lifetime test of the full formula of Roundup (remember, pesticide corporations only test the weaker active chemical, glyphosate) has been pulled because it is…. inconsistent.  Independent scientists are in uproar. 

In addition, the OECD’s Test Guideline (TG) toxicity test methods further specify the very insensitive methods that end up discovering nothing but quasi-poisoning from chronic exposures, according to non-industry scientists.

Can you see how non-industry scientists don’t want to use TG’s that don’t show delicate results?  So they don’t.

Another crazy irony is that many of these unpublished studies that are accepted by the big guys years ago, were conducted before Good Laboratory Practice was invented.  Scientists are repeatedly asking these massive agrichemical organisations that are meant to represent YOU and ME, to see the studies.  They are repeatedly denied.

So let’s make it clear, the agrichemical industry rejects independent peer reviewed science because it is not GLP yet many of the current cited (but unpublished) studies that apparently declare the chemicals safe are non GLP anyway because they are so old?   Yes.

Caveat:  I have researched reproductive and developmental toxicity of glyphosate – and these old studies held by the regulatory agencies are largely non-GLP.  Yet when I look at the studies that form the ADI for glyphosate USA & Europe they don’t seem to be GLP either.  Furthermore the study for ADI for the WHO is questionable as to whether it is GLP or not.

The simple truth is that peer reviewed, publicly funded industry research studies are more likely to find bad results that harm people. 

They are far less likely to produce false negative error (finding no risk when it is actually there) than the toxicity studies sponsored by the substance’s manufacturer, which follow rigid and limited OECD protocols. [2]

Non-industry researchers’ methods vary greatly, but what makes them valid, is an age old process called ‘peer review’.  If someone thinks someone’s work is crap/useless/rubbish it can be debunked.

GLP “specifies nothing about the quality of the research design, the skills of the technicians, the sensitivity of the assays, or whether the methods employed are current or out-of-date.”

Independent scientists test at more realistic doses than the OECD protocols use.  They find toxicity at lower doses.  This is conveniently ignored by the Big Three (EPA, FAO/WHO & EU) because of the loophole of requiring Good Laboratory Practice.

Companies hid behind the GLP loophole for Bisphenal A for too long.  A study in 2005 found that chemical manufacturers continued to discount these published findings that show significant effects occurred below the predicted “safe” or reference dose.  No industry-funded studies reported significant effects of low doses of BPA, although more than 90% of government-funded studies have reported significant effects[3] .

The history of Bisphenal A is the perfect example of how GLP works. In 2009 publicly funded scientists published a peer reviewed paper criticising regulatory fixation of GLP on both sides of the Atlantic [4].

Wikipedia notes that:  Tens of thousands of published findings of toxicity from chronic toxicity have been excluded from risk assessment, a large fraction of which find toxicity at lower dose than OECD tests. Not all these independent results are high quality, but many are; and critically, they are financially disinterested.

At this point in time, it would seem that the fox is guarding the henhouse.

Perhaps it’s time for a different system:

RITE: Requirement for Independent Toxicity Evaluations.

A system that promotes transparency – not corporate protectionism.

 

[1]Klimisch, H. J., M. Andreae, et al. (1997). A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharmacol 25(1): 1-5.

[2]  Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research. JAMA  2003; 289:454e65.

– Fagin D, Lavelle M. Center for Public Integrity. Toxic Deception: How the Chemical Industry Manipulates Science, Bends the Law and Endangers Your Health. 2nd Edition. Monroe, ME: Common Courage Press, 1999:
– Swaen GM, Meijers JM. Influence of design characteristics on the outcome of retrospective cohort studies. Br J Ind Med 1988;45:624e9.

[3] vom Saal FS, Hughes C 2005. An Extensive New Literature Concerning Low-Dose Effects of Bisphenol A Shows the Need for a New Risk Assessment. Environ Health Perspect 113:926-933.

[4]  Myers JP, Vom Saal FS. et al. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environmental Health Perspectives 2009, 117, 309–15

 

 

 

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