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German regulator leaps to defend glyphosate

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Published: 15 January 2015
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NGO urine monitoring studies dismissed, breast milk findings ignored. Claire Robinson reports

The German Federal Institute for Risk Assessment (BfR) has sprung to the defence of glyphosate ahead of its expected 2015 re-approval after monitoring studies by NGOs and other research groups found glyphosate in human urine. Employees of BfR have published a paper which predictably concludes that the levels of glyphosate found in urine are of no concern because the exposure estimates derived from the urine levels are below the ADI (acceptable daily intake). The ADI is the level of the pesticide that regulators assume is safe to ingest over a long-term period.

In order to see any progress on this issue, long-term animal feeding experiments must be carried out using doses set at the ADI and below. The ADI for any pesticide has never been tested. Instead supposedly safe doses are extrapolated from higher doses claimed in secret industry experiments not to cause any toxic effects on the animals. This is not scientifically valid, since low doses of some toxins, notably endocrine disruptors, have a more toxic effect than higher doses.

Regulators, including BfR, have not caught up with this principle of toxicology, though scientists have been publishing on the topic since the early 1990s. Instead there are frantic attempts at the level of the EU Commission to delay regulation of endocrine disruptors.

Research scientists who want to see a real shift in public health protection need to forget about testing high, known toxic doses of pesticides and start testing doses at or below the ADI. Also they must use the complete formulation that you and I are exposed to, not just the isolated “active ingredient” glyphosate, which is the substance tested by industry and assessed by regulators.

As far as we know, there are only two controlled lab studies on glyphosate and glyphosate-based herbicides that tested these realistic doses. One is the in vitro study by Thai researchers, which found that glyphosate alone stimulated the growth of breast cancer cells at minute concentrations as low as 10(-12) M or 169 ppq (parts per quadrillion). The other is the Seralini long-term rat feeding trial with Roundup, which found toxic effects in rats fed levels of Roundup below the permitted level in drinking water in Europe.

Strangely, BfR’s paper does not address the findings by Moms Across America and Sustainable Pulse of high levels of glyphosate in American women’s breast milk. The levels were from 760 to 1600 times higher than the EU permitted level in drinking water. This is an odd omission, since BfR specifically cites and addresses the urine figures in the same report. In case BfR missed the point, the breast milk results mean that babies are drinking levels of glyphosate that even regulators think may not be safe.

Germany has taken the role of defender of glyphosate because it is the rapporteur member state for the pesticide, responsible for liaising between industry and the EU Commission and member states over the European regulatory authorisation. It helped glyphosate through its 2002 European authorisation by downplaying harm found in industry studies.

All in all, the BfR paper on glyphosate levels in urine is the latest example of an unseemly and growing trend among regulators – of defending industry and their own position simultaneously while risking public health.
—

A critical review of glyphosate findings in human urine samples and comparison with the exposure of operators and consumers

Lars Niemann, Christian Sieke, Rudolf Pfeil, Roland Solecki
J. Verbr. Lebensm. 8 January 2015
DOI 10.1007/s00003-014-0927-3
http://link.springer.com/article/10.1007/s00003-014-0927-3 (open access)

Abstract

For active substances in plant protection products (PPP) with well defined urinary elimination, no potential for accumulation and virtually no metabolism, measuring of urine levels could be a powerful tool for human biomonitoring. Such data may provide reliable estimates of actual internal human exposure that can be compared to appropriate reference values, such as the ‘acceptable daily intake (ADI)’ or the ‘acceptable operator exposure level (AOEL)’. Traces of the active compound glyphosate were found in human urine samples, probably resulting either from occupational use for plant protection purposes or from dietary intake of residues. A critical review and comparison of data obtained in a total of seven studies from Europe and the US was performed. The conclusion can be drawn that no health concern was revealed because the resulting exposure estimates were by magnitudes lower than the ADI or the AOEL. The expected internal exposure was clearly below the worst-case predictions made in the evaluation of glyphosate as performed for the renewal of its approval within the European Union. However, differences in the extent of exposure with regard to the predominant occupational and dietary exposure routes and between Europe and North America became apparent.

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