MADGE Australia Inc · @MADGEAustralia
6th Aug 2010 from Twitlonger
US #ND: What u need 2 know about the #Monsanto #GMO canola safety testing:
Australian ABC Radio National Background Briefing April 18: Broke news that Australian Food Standards (FSANZ) science team speaking for the safety of GM canola had not read Monsanto material provided in support of the crop.
April 13,15,28 FSANZ infer that it's OK for them to rely solely on Monsanto material for GM food safety assessments because Monsanto is obliged to prove "Good Laboratory Practice" and be "Externally Audited". [April 13 (letter - FSANZ CEO) , 15&28;(Bush Telegraph - FSANZ Chief scientist)]
Good Laboratory Practice?: As a result of horrendous lab fraud discovered in the testing of chemicals and pesticides in the 1970's (animals so badly decomposed they could only be recognised as purple puddles on the floor) the US FDA and EPA developed requirements for such basic things as correct recording of data (not using pencil etc) and archiving test materials as a token gesture to bring legitimacy to in-house testing process. A Monsanto "revolving door" scientist (Monsanto - chemical testing company - Monsanto) was one of three who went to jail over the fraud.
Here's the news: The FSANZ safety assessment document cited 32 'studies' from Monsanto. On request FSANZ provided the Monsanto material to MADGE, which included information on 30 of these studies. The Statements of Compliance to Good Laboratory Practice are typically found inside the front cover of the study.
In summary:
- In 15 studies Monsanto self-reported that they failed to meet compliance with Good Laboratory Practice.
- In 10 studies Monsanto did not provide a Statement of Compliance.
- In 3 studies Monsanto said it complied with Good Laboratory Practice.
- In 1 study Monsanto reported that it didn't 'significantly deviate' from GLP.
- In 1 study Monsanto said it didn't have to comply.
The Monsanto material contains no evidence of external auditing, where 'external' means outside and beyond the influence of Monsanto. The Quality Assurance Statements and Protocols were signed by Auditors or Quality Assurance Representatives of Monsanto, usually from the same Monsanto Division that was developing or testing the GM materials.
Just a few of the reasons why they failed?
"Data documentation practices were not always in full GLP compliance."
"The test and control substances were not characterized prior to the study and documentation of the raw data was not fully compliant with GLP requirements."
"Study personnel recorded some raw data in pencil. Permanent copies of these data were made and placed in the data."
"There are several corrections to raw data which were not made in a manner compliant with GLP requirements."
Even the most basic data is suspect, and none of this was noted by FSANZ (then ANZFA) in their document presented to the public for review and comment.
It is our impression that the 'safety' of the GM canola crop will be equivalent to the financial risk that Monsanto has decided to carry in respect of the crop, should they be held liable for damage in the future, and not related to the health safety for human beings and non-impact on environment.