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Answers

Question

Will it ever get to the point where you have enough respect for the people you are providing these chemical laden foods to, or your science to conduct studies on the effects that consuming crops sprayed with glyphosate have had upon Americans health so far? Since we are obviously getting the special treatment! Have you done any studies on how the new combination of glyphosate 2,4D exposed crops will effect human health?

Submitted by: Scott Lemoine


Answer

Expert response from Dan Goldstein

Former Senior Science Fellow and Lead, Medical Sciences and Outreach, Monsanto Company

Wednesday, 13/01/2016 14:29

We undertake a comprehensive pre-market safety assessment using animal species directly dosed with known concentrations of test material. This allows one to establish a no-observable-adverse-effect level in animals. A safety factor - typically 100-fold or greater for pesticides - is then applied to determine a maximal permissible long term exposure. This establishes safety without the need to use human subjects. Studies of this type are performed using internationally accepted guidelines and are subject to audit by regulatory authorities. This represents the utmost in respect for the individuals who are exposed to our products and for quality science.

 

Drugs are given to humans in doses that are expected to have a physiological effect; and one expects both therapeutic and, as a rule, adverse effects. As such, in the U.S. and other jurisdictions, drug safety and efficacy must ultimately be demonstrated with human clinical trials. Such testing takes place only after pre-clinical testing in animals establishes an appropriate dose and reasonable lack of toxicity, contingent upon the purpose of the drug (i.e.- a chemotherapeutic agent for cancer often has significant side effects). The labeled uses of a drug reflect a balance between risks and benefits. Human clinical trials with drugs have their own ethical challenges and must be conducted with appropriate respect for experimental subjects as overseen by institutional ethics boards. 

 

Foods, food additive, and pesticide safety assessment has never been based on human trials. Such materials are not expected to produce a pharmacological effect (beyond nutritional value and the obvious avoidance of starvation or malnutrition). Permissible intakes are expected to be, by law, sufficiently low that no unreasonable risk of adverse effects is entailed. It is generally not considered ethically appropriate to perform clinical trials to demonstrate toxicity of a food additive or pesticide in humans. The latter would require dosing far in excess of that expected or permitted. The nature of anticipated toxic effects and the safety margin - the difference between the maximal permitted dose and a dose having an adverse effect - could only be ascertained in humans by pushing the dose in humans to toxic levels. 

 

Both glyphosate and 2,4-D have been subject to detailed safety assessments. We do not perform animal toxicology studies on combinations of chemistry as the number of possible combinations is virtually endless. What we can do is look for common mechanisms of toxicity (shared receptors) or shared toxicological outcomes as well as shared metabolic or excretory pathways which might permit chemistries to interact. In the case of 2,4-D and glyphosate, none of these possible mechanisms of action exist. 

 

While not all countries around the globe permit the cultivation of GM crops, virtually all countries with intact regulatory systems permit the import of GM crops, food, and feed for consumption, and glyphosate is used in some 160 countries around the world. In the U.S., as in many countries, we have a robust system to assure food and pesticide safety. 

Answer

Expert response from Dan Goldstein

Former Senior Science Fellow and Lead, Medical Sciences and Outreach, Monsanto Company

Wednesday, 13/01/2016 14:29

We undertake a comprehensive pre-market safety assessment using animal species directly dosed with known concentrations of test material. This allows one to establish a no-observable-adverse-effect level in animals. A safety factor - typically 100-fold or greater for pesticides - is then applied to determine a maximal permissible long term exposure. This establishes safety without the need to use human subjects. Studies of this type are performed using internationally accepted guidelines and are subject to audit by regulatory authorities. This represents the utmost in respect for the individuals who are exposed to our products and for quality science.

 

Drugs are given to humans in doses that are expected to have a physiological effect; and one expects both therapeutic and, as a rule, adverse effects. As such, in the U.S. and other jurisdictions, drug safety and efficacy must ultimately be demonstrated with human clinical trials. Such testing takes place only after pre-clinical testing in animals establishes an appropriate dose and reasonable lack of toxicity, contingent upon the purpose of the drug (i.e.- a chemotherapeutic agent for cancer often has significant side effects). The labeled uses of a drug reflect a balance between risks and benefits. Human clinical trials with drugs have their own ethical challenges and must be conducted with appropriate respect for experimental subjects as overseen by institutional ethics boards. 

 

Foods, food additive, and pesticide safety assessment has never been based on human trials. Such materials are not expected to produce a pharmacological effect (beyond nutritional value and the obvious avoidance of starvation or malnutrition). Permissible intakes are expected to be, by law, sufficiently low that no unreasonable risk of adverse effects is entailed. It is generally not considered ethically appropriate to perform clinical trials to demonstrate toxicity of a food additive or pesticide in humans. The latter would require dosing far in excess of that expected or permitted. The nature of anticipated toxic effects and the safety margin - the difference between the maximal permitted dose and a dose having an adverse effect - could only be ascertained in humans by pushing the dose in humans to toxic levels. 

 

Both glyphosate and 2,4-D have been subject to detailed safety assessments. We do not perform animal toxicology studies on combinations of chemistry as the number of possible combinations is virtually endless. What we can do is look for common mechanisms of toxicity (shared receptors) or shared toxicological outcomes as well as shared metabolic or excretory pathways which might permit chemistries to interact. In the case of 2,4-D and glyphosate, none of these possible mechanisms of action exist. 

 

While not all countries around the globe permit the cultivation of GM crops, virtually all countries with intact regulatory systems permit the import of GM crops, food, and feed for consumption, and glyphosate is used in some 160 countries around the world. In the U.S., as in many countries, we have a robust system to assure food and pesticide safety.