I gather that primary purpose of 'Roundup Ready' crops is to create higher crop yields by way of adding the ability to apply Roundup herbicide throughout the growth season rather than only before planting as with traditional farming. How do you respond to the April 2013 peer reviewed study in Entropy magazine, authored by Stephanie Seneff of MIT and Anthony Samsel, that asserts that Roundup's active ingredient, glyphosate, could be linked to a range of health problems and diseases, including Parkinson's, infertility and cancers? Would the GMO industry be willing to fund truly independent research along the same lines so we can get to the bottom of this, in the interest of public health?

Expert response from Bill Heydens

Former Regulatory Product Safety Assessment Lead, Bayer Crop Science

Tuesday, 25/11/2014 12:49

Several questions are posed, and each is important to address. This response is broken into two sections:

1. Samsel and Seneff, with information about glyphosate reregistration
2. Independent research

1. The Samsel and Seneff paper attempts to link glyphosate to a list of health problems without providing any data or evidence to support these claims. These are all variables that are increasing over a period of time and therefore provide a sense of correlation, but this is not to be confused with causation. Included at the bottom are some responses already available on GMOAnswers.com that addresses your question; however, I have also included current and up-to-date information on glyphosate as a result of reevaluation in the EU.

Glyphosate is undergoing a comprehensive reevaluation in the EU; it is one of several active ingredients in the second group of active ingredients to go through the EU approval renewal program. This reevaluation is part of a standard procedure for crop protection products, which must undergo a renewal process controlled by the European Commission. Germany is the Rapporteur member state responsible for this renewal process, and the German federal institute of risk assessment (BfR) is responsible for conducting an assessment of health risks and sending the report to the European Food Safety Authority (EFSA).

This renewal process considers the vast body of scientific data from all glyphosate manufacturers, both existing and new data generated since the last EU review in 2002, as well as information available in the scientific literature. The European Glyphosate Task Force (GTF) was formed to compile and submit a joint dossier that contains all this information from a consortium of 24 companies.

In addition to documents used in the first EU assessment of glyphosate back in 2002, the BfR evaluated more than 150 new toxicological and other relevant studies, which are available for your review: finalized draft report for the reevaluation of glyphosate and FAQ on the health assessment of glyphosate. Furthermore, close to 1,000 publications from scientific journals were included in the review.

The German BfR has now completed its draft reassessment report and sent it on to EFSA for further evaluation. The report’s conclusions broadly confirm earlier regulatory assessments regarding glyphosate’s toxicological/risk profile, noting that it has limited toxicity for humans and animals; it was noted that glyphosate is not neurotoxic, mutagenic or carcinogenic; it does not produce adverse effects on reproduction or development, and it does not have endocrine-disrupting properties. This report is consistent with all previous evaluations of glyphosate by regulatory authorities globally (e.g., the United States, Canada, Japan, Australia), which have concluded that glyphosate does not pose any unacceptable risk to human health.

• Andrew Kniss, associate professor of weed ecology and management at the University of Wyoming, provides a thorough response addressing how two incidences occurring at the same time does not signify a causal relationship.
• Peter Olins, biochemist and cofounder of UltimateGlutenFree.com, discusses Seneff’s 2013 study point by point in this article. 
• Steve Savage, a biotechnology consultant with more than 30 years of agricultural experience, addresses the Samsel and Seneff claim of a possible link between celiac disease and the use of glyphosate by exposing that “a key element of the authors’ argument is based on a single example of a study with fish (Senapati et al., 2009). He also discusses how this paper that was used as the source of literature “is itself deeply flawed, and it is also irrelevant.”
• The website Spurious Correlations uses unrelated sets of data and presents a correlation, but the variables are clearly not connected and have no causal link. This is a representation of how data that are increasing/decreasing over time can be misused to represent causation. This is similar to the health scare attempt that the Samsel and Seneff paper depicts with glyphosate. For information on the safety of glyphosate, my colleague John Swarthout addresses the topic of glyphosate and cancer.

2. Your last question, however, brings up an important concept: independent research. This remains critical in science, not only to continue with discovery, innovation and “breakthroughs,” but also to address reconstructability and reproducibility of the study parameters and results. We absolutely support independent research, which is performed in the private, public and governmental arenas:

• Contract Research Organizations (CROs): these are organizations, typically laboratories, outsourced to perform studies. While they may be paid to conduct studies by companies, all of their regulatory studies are subject to inspection and penalties by regulatory agencies. Considering that the business model for CROs is to perform work for other companies and regulatory agencies, it would be plain bad business to put at risk their ability to perform studies by fabricating data.
• Universities: University researchers regularly evaluate published studies, as well as conduct research on our products, and then publish additional review articles; these efforts are funded by grants. Larger institutions receive anywhere from 90 to 98 percent of their research funding from sources other than industry (that includes federal funding as the largest percentage, state funding, associations and foundations, etc.). Public universities often make this information available on their websites.
• Governmental and Regulatory bodies also sponsor independent research. For instance, 50 studies conducted in Europe and funded by the European Commission (not GMO industry), and a total of more than 400 research groups that performed these studies from 2001 to 2010, can be found in the aptly named “A Decade of EU-Funded GMO Research.” Additionally, more than 600 studies conducted independently and published in scientific literature are collated in the Biofortified GENERA database on the safety of GMO crops.

Expert response from Community Manager

Tuesday, 25/11/2014 12:43

Several questions are posed, and each is important to address. This response is broken into two sections:

1. Samsel and Seneff, with information about glyphosate reregistration
2. Independent research

1. The Samsel and Seneff paper attempts to link glyphosate to a list of health problems without providing any data or evidence to support these claims. These are all variables that are increasing over a period of time and therefore provide a sense of correlation, but this is not to be confused with causation. Included at the bottom are some responses already available on GMOAnswers.com that addresses your question; however, I have also included current and up-to-date information on glyphosate as a result of reevaluation in the EU.

Glyphosate is undergoing a comprehensive reevaluation in the EU; it is one of several active ingredients in the second group of active ingredients to go through the EU approval renewal program. This reevaluation is part of a standard procedure for crop protection products, which must undergo a renewal process controlled by the European Commission. Germany is the Rapporteur member state responsible for this renewal process, and the German federal institute of risk assessment (BfR) is responsible for conducting an assessment of health risks and sending the report to the European Food Safety Authority (EFSA).

This renewal process considers the vast body of scientific data from all glyphosate manufacturers, both existing and new data generated since the last EU review in 2002, as well as information available in the scientific literature. The European Glyphosate Task Force (GTF) was formed to compile and submit a joint dossier that contains all this information from a consortium of 24 companies.

In addition to documents used in the first EU assessment of glyphosate back in 2002, the BfR evaluated more than 150 new toxicological and other relevant studies, which are available for your review: finalized draft report for the reevaluation of glyphosate and FAQ on the health assessment of glyphosate. Furthermore, close to 1,000 publications from scientific journals were included in the review.

The German BfR has now completed its draft reassessment report and sent it on to EFSA for further evaluation. The report’s conclusions broadly confirm earlier regulatory assessments regarding glyphosate’s toxicological/risk profile, noting that it has limited toxicity for humans and animals; it was noted that glyphosate is not neurotoxic, mutagenic or carcinogenic; it does not produce adverse effects on reproduction or development, and it does not have endocrine-disrupting properties. This report is consistent with all previous evaluations of glyphosate by regulatory authorities globally (e.g., the United States, Canada, Japan, Australia), which have concluded that glyphosate does not pose any unacceptable risk to human health.

• Andrew Kniss, associate professor of weed ecology and management at the University of Wyoming, provides a thorough response addressing how two incidences occurring at the same time does not signify a causal relationship.
• Peter Olins, biochemist and cofounder of UltimateGlutenFree.com, discusses Seneff’s 2013 study point by point in this article. 
• Steve Savage, a biotechnology consultant with more than 30 years of agricultural experience, addresses the Samsel and Seneff claim of a possible link between celiac disease and the use of glyphosate by exposing that “a key element of the authors’ argument is based on a single example of a study with fish (Senapati et al., 2009). He also discusses how this paper that was used as the source of literature “is itself deeply flawed, and it is also irrelevant.”
• The website Spurious Correlations uses unrelated sets of data and presents a correlation, but the variables are clearly not connected and have no causal link. This is a representation of how data that are increasing/decreasing over time can be misused to represent causation. This is similar to the health scare attempt that the Samsel and Seneff paper depicts with glyphosate. For information on the safety of glyphosate, my colleague John Swarthout addresses the topic of glyphosate and cancer.

2. Your last question, however, brings up an important concept: independent research. This remains critical in science, not only to continue with discovery, innovation and “breakthroughs,” but also to address reconstructability and reproducibility of the study parameters and results. We absolutely support independent research, which is performed in the private, public and governmental arenas:

• Contract Research Organizations (CROs): these are organizations, typically laboratories, outsourced to perform studies. While they may be paid to conduct studies by companies, all of their regulatory studies are subject to inspection and penalties by regulatory agencies. Considering that the business model for CROs is to perform work for other companies and regulatory agencies, it would be plain bad business to put at risk their ability to perform studies by fabricating data.
• Universities: University researchers regularly evaluate published studies, as well as conduct research on our products, and then publish additional review articles; these efforts are funded by grants. Larger institutions receive anywhere from 90 to 98 percent of their research funding from sources other than industry (that includes federal funding as the largest percentage, state funding, associations and foundations, etc.). Public universities often make this information available on their websites.
• Governmental and Regulatory bodies also sponsor independent research. For instance, 50 studies conducted in Europe and funded by the European Commission (not GMO industry), and a total of more than 400 research groups that performed these studies from 2001 to 2010, can be found in the aptly named “A Decade of EU-Funded GMO Research.” Additionally, more than 600 studies conducted independently and published in scientific literature are collated in the Biofortified GENERA database on the safety of GMO crops.