Unpublished and largely NOT GLP: the double standards of international assessment agencies & the agrichemical industry.

2012-12-04 DSC_0977Here we have all the studies listed as part of the evaluations for toxicity for glyphosate for reproductive and developmental toxicity (for the pregnant mother and foetus) and whether the studies held by the main international regulatory agencies follow the OECD protocol of Good Laboratory Practice (GLP), or not.

These studies are from the USA EPA, WHO and EU’s EFSA.  The big kahunas of international assessment for you and me.

Each of these studies advise ‘No Observable Adverse Effect Level’ (NOAEL) for glyphosate on food.   NOAEL declares a safe level at which we can consume glyphosate – so therefore these studies decide the toxicity levels for the pregnant mother and foetus of the pesticide glyphosate on our food.  But there are also other studies (carcinogenic and so on) that the the three major organisations in the world look at before they then decide their recommended ADI, Acceptable Daily Intake, which is the amount of glyphosate that can be ingested orally on a daily basis without an appreciable health risk.  So therefore these studies are pretty important for our health.

Wouldn’t it be great if the studies were up to date, revealed the latest research findings and were financially independent from the organisations that would benefit from the highest sales of the product?

Every study is submitted by an agrichemical company. Nothing listed is submitted by an independent research institution without financial interest in the outcome of the assessment.  However today, many studies put forward for consideration by independent submitters without financial interest are rejected because they do not follow OECD test guidelines system, and one of these protocols is to follow GLP.

Now please kindly consider the studies currently held with these three major organisations in the world that provide the assessments for the safety of the pregnant mother and foetus.  Are they GLP?

 

EPA – 1990 last review of glyphosate. 4 studies only. Nothing GLP

(1)    Rodwell, D.E.; Tasker, E.J.; Blair, A.M.; et al. (1980): Teratology Study in Rats: IRDC No. 401-054. MRID 00046362 Unpublished. Pre GLP.  IRDC no. 999-021; received May 23, 1980 under 524-308; prepared by International Research and Development Corp., submitted by Monsanto Co., Washington, D.C.; CDL:242516-A)

(1)    Rodwell, D.E.; Tasker, E.J.; Blair, M.; et al. (1980): Teratology Study in Rabbits: IRDC No. 401-056. MRID 00046363. Unpublished. Pre GLP.   study received May 23, 1980 under 524-308; prepared by International Research and Development Corp., submitted by Monsanto Co., Washington, D.C.; CDL:242516-B).  This unpublished non GLP study forms the ADI (ARfD) for glyphosate in the USA.

(2)    Street, R. (1982): Letter sent to R.Taylor dated Jul 6, 1982:  Roundup herbicide: Addendum to pathology report for a three-generation reproduction study in rats with glyphosate. MRID 00105995  Unpublished, pre GLP study received Jul 7, 1982 under 524-308; submitted by Monsanto Co., Washington, DC; CDL:247793-A)

(3)    Reyna, M. (1990): Two Generation Reproduction Feeding Study with Glysophate in Sprague-Dawley Rats: Lab Project No: MSL-10387. MRID 41621501 Unpublished. GLP NOT MENTIONED.  Study prepared by Monsanto Agricultural Co.  1158

 

FAO/WHO –  Cites all their studies are GLP, but by cross referencing with the European Union studies that mention that they are ‘GLP like’, and according to the way these organisations adhere to the rule of GLP, it 2/6 of these studies could be ruled out as not strictly being GLP.

The study that establishes the FAO/WHO ADI is by Atkinson et al., 1993b. FAO/WHO mentions that the study was performed ‘in compliance with the principles of GLP’.  But following the below comments where the FAO/WHO says ‘performed in compliance’ and the EU says for 2 studies that are the same: ‘GLP like’ one could surmise that this was yet another study that is not fully GLP.  It would be great to see the research but this most important study that sets the ADI for all the countries that follow Codex, is like all the others unpublished and unavailable to scientists of public, impartial institutions to review.

1. (Brooker et al., 1992): Brooker, A.J., Myers, D.P., Parker, C.A., Offer, J.M., Singh, H., Anderson, A. & Dawe, I.S. (1992) The effect of dietary administration of glyphosate on reproductive function of two generations in the rat. Unpublished. In compliance with GLP (but EU says NOT GLP, “GLP like”).  Report No. CHV 47/911129, dated 14 May 1992, from Huntingdon Research Centre Ltd., Huntingdon, England. Submitted to WHO by Cheminova A/S, Lemvig, Denmark.

2. Moxon, M. E. 2000 (2): Glophosate acid: multigeneration reproduction toxicity in rats. Unpublished.  In compliance with GLP. Report no. CTL/P/6332, study no. RR0784, 2000, submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland, prepared by Zeneca Agrochemicals, Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, England.

3) (Brooker et al., 1991b) (3): Brooker, A.J., John, D.M., Anderson, A. & Dawe, I.S. (1991b) The effect of glyphosate on pregnancy of the rat (incorporates preliminary investigation). Unpublished. In compliance with GLP. Report No. CHV 43 & 41/90716, dated 14 October 1991, from Huntingdon Research Centre Ltd., Huntingdon, England. Submitted to WHO by Cheminova A/S, Lemvig, Denmark.

4. Moxon, M.E. (1996a) (2): Glyphosate acid: developmental toxicity study in the rat. Unpublished. In compliance with GLP.  Report No.CTL/P/4819, study No. RR0690, dated 27 March 1996, CTL/P/4819/amendment-001, dated 20 November 2002, from Zeneca Agrochemicals, Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, England. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland.

5. (Brooker et al., 1991a): Brooker, A.J., Brennan, C., John, D.M., Anderson, A. & Dawe, I.S. (1991a) The effect of glyphosate on pregnancy of the rabbit (incorporates preliminary investigations). Unpublished. In compliance with GLP ( But the EU says NOT GLP, “GLP like”).  Report No. CHV 45 & 39 & 40/901303, dated 14 October 1991, from Huntingdon Research Centre Ltd., Huntingdon, England. Submitted to WHO by Cheminova A/S, Lemvig, Denmark.

6. Moxon, M.E. (1996b) (4):Glyphosate acid: developmental toxicity study in the rabbit. Unpublished. In compliance with GLP.  Report No.CTL/P/5009, study No. RB0709, dated 2 July 1996, from Zeneca Agrochemicals, Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, England. Submitted to WHO by Syngenta Crop Protection AG, Basel, Switzerland.

 

European Union   – studies sourced from Earth Open Source file.  19/22 studies cited not strictly GLP.

(2)    Lankas, G.R.; Hogan, G.K. (1981): A Lifetime Feeding Study of Glyphosate (Roundup Technical) in Rats: Project No. 772062. Unpublished. Pre GLP Study received Jan 20, 1982 under 524-308; prepared by Bio/dynamics, Inc., submitted by Monsanto Co., Washington, D.C.; CDL:246617-A; 246618; 246619; 246620; 246621. MRID 00093879. This unpublished Pre GLP study forms the ADI for glyphosate in Europe.

(3)    Brooker, A.J., John, D.M., Anderson, A. & Dawe, I.S. (1991b): The effect of glyphosate on pregnancy of the rat (incorporates preliminary investigation). Unpublished. GLP.  report No. CHV 43 & 41/90716, dated 14 October 1991, from Huntingdon Research Centre Ltd., Huntingdon, England. Submitted by Monsanto and Cheminova .

(4)    Suresh, T.P. (1993):  Two generation reproduction study in Wistar rats. Rallis India, Ltd., Rallis Agrochemical Research Station, Bangalore, India. Unpublished. NOT GLP, “GLP like”. Study no. TOXI:885-RP-G2. 30. Dates of experimental work: May 1991-April 1992.  Submitted by Feinchemie

(5)    Brooker, A.J., Myers, D.P., Parker, C.A., Offer, J.M., Singh, H., Anderson, A. & Dawe, I.S. (1992):  The effect dietary administration of glyphosate on reproductive function of two generations in the rat. Unpublished.  NOT GLP, “GLP like”.  report No. CHV 47/911129, dated 14 May 1992, from Huntingdon Research Centre Ltd., Huntingdon, England. Submitted by Cheminova and Monsanto.

(6)    Brooker, A.J.; Homan, B.A.; Hadley, J.C. and Offer, J.M. (1991):  Dietary range finding study of glyphosate in pregnant rats and their juvenile offspring. Unpublished. NOT GLP, “GLP like”. Report no. CHV 42/90619. Huntington Research Centre, Huntington, England. Dates of experimental work: 11 November 1989-12 January 1990. Submitted by Monsanto and Cheminova.

(7)    Reyna M.S., 1990: Two generation reproduction feeding study with glyphosate in Sprague Dawley rats. Unpublished. Pre- GLP. Monsanto Agricultural Co. (MRID 41621501) EHL88038, Laboratory project nos. MSL-10387 &/or ML-88-106.  Submitted by Monsanto & Cheminova

(8)    Bhide, M.B. 1988: Report on effect of glyphosate in the reproductive process – Segment IV – Three generation reproduction study with albino rats using glyphosate. Unpublished.  Pre GLP.  Institute of Toxicology, Bombay, India. report no. not indicated, dates not given, does not comply with GLP. Luxan submitter.

(9)    Bhide, M.B. 1988: Report on effect of glyphosate on fertility and general reproductive performance (Segment I). Unpublished. Pre GLP.  Indian Institute of Toxicology, Bombay, India. , report no. not indicated, dates not given, does not comply with GLP. Barclay submitter.

(10)Antal, A. 1985:  Three-generation reproduction study in rats with the oral administration of glyphosate. Unpublished. Pre GLP. Report no. not indicated. Does not comply with GLP. Toxicological Laboratory of Plant Protection and Agrochemical Centre, Keszthely, Hungary. Submitted by Alkaloida

(11)Schroeder, R.E. and Hogan, G.K. 1981:  A three generation reproduction study in rats with glyphosate. Bio/dynamics Inc., East Millstone, New Jersey, USA, on behalf of Monsanto.  Unpublished. Pre GLP. Report no.BDN-77-417 Project no.77-2063. Dates of experimental work: 14 June 1978-9 April 1980.  Submitted by Monsanto and Cheminova

(12)Chan, P. C.; Mahler, J. F. 1992: NTP Technical Report on toxicity studies of glyphosate (CAS No. 1071-83-6) administered in dosed feed to F344/N rats and B6C3F1 mice. Published and GLP. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, National Toxicology Program: Research Triangle Park, NC, 1992; pp 12-13, 24.

(13)Suresh, T.P. (1991), Two generation reproduction Teratogenicity study in Wistar rats. Rallis India, Ltd., Rallis Agrochemical Research Station, Bangalore, India on behalf of Feinchemie. Unpublished. Pre GLP.  Study no. TOXI:883-TER-R. Dates of experimental work: Nov/Dec 1990.

(14)Bhide, M.B. 1986: Report on effect of glyphosate in the reproductive process – Segment II – Teratological study. Unpublished. Pre GLP.  Institute of Toxicology, Bombay, India. report no. not indicated, dates not given, does not comply with GLP. Barclay and Luxan submitters.

(15)Tasker, E.J. and Rodwell, D.E. 1980: Teratology study in rats. Unpublished. Pre-GLP. IRDC.  Report No. IR-79-016. (Monsanto Co., 1980a MRID 00046362 and Tasker, 1980a). International Research and Development Corp., Mattawan, Michagan.   Dates of experimental work: 16 April 1979-12 May 1979.  Submitted by Monsanto & Cheminova.

(16)Anonym 1981:  Teratological investigation of glyphosate in rats and rabbits. This report on a further teratogenicty study in rats was prepared by the Dept. Toxicology,Plant Protection and Agrochemical Centre, Keszthely, Hungary.  Unpublished. Pre GLP. No author, no study dates or number given.

(17)Bhide, M.B. 1988: Effect of glyphosate on reproductive processes. Segment III – Effect on suckling and lactating dams. Unpublished. Pre GLP  Institute of Toxicology, Bombay, India. Not GLP. No report no.

(18)Suresh, T.P. (1993),  : Teratogenicity study in rabbits. Study no. TOXI:884-TER-RB.  Rallis India, Ltd., Rallis Agrochemical Research Station, Bangalore, India. Unpublished. GLP according to self certification from the laboratory(?) Dates of experimental work: Dec 24 1991 – 6 March 1992.  Submitted by ??????

(19) Rodwell DE; Tasker EJ; Blair M; et al. (1980): Teratology Study in Rabbits. Unpublished. Pre GLP. Monsanto Company. 1980b. Report no. IR-79-018. MRID No. 00046363. IRDC No. 401-056. International Research and Development Corp.  Submitted by Monsanto & Cheminova

(20)Brooker, A.J., Brennan, C., John, D.M., Anderson, A. & Dawe, I.S. (1991a): The effect of glyphosate on pregnancy of the rabbit (incorporates preliminary investigations). Unpublished.  NOT GLP, “GLP like”. Report No. CHV 45 & 39 & 40/901303, dated 14 October 1991, from Huntingdon Research Centre Ltd., Huntingdon, England. Submitted as part of a joint dossier by Monsanto and Cheminova.

(21)Bhide, M.B. and Patil, U.M. 1989: Rabbit teratology study with glyphosate. Unpublished. Not GLP.  IIT, India. Project no. 1086.  Submitted by Barclay & Luxan.

(22)Zhu, Y., Jiang, X and Tan, G. 1984: Test on the toxicity of a new herbicide: glyphosate. Gui Yan Medical University, China. Published in: Environmental Science, 5 (2), 52-54.  Pre GLP Submitted by Barclay.

 

Perhaps it is time for a different system. One that promotes transparency, consistency and independent science.

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