Friday, 29 July 2016 / TRUTH-OUT.ORG

Eat at Your Own Risk: Flawed FDA Risk Assessments Strengthen Arguments for Labeling GMOs

Wednesday, 25 February 2015 09:19 By Alex James, Truthout | Op-Ed
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Eat at Your Own Risk: Flawed FDA Risk Assessments Strengthen Arguments for Labeling GMOs(Image: Jared Rodriguez / Truthout)

Help Truthout keep publishing stories like this: They can’t be found in corporate media! Make a tax-deductible donation today.

For the past two decades, developers of genetically engineered (GE) crops and their corporate allies have maintained that because their products are so obviously safe, there is no need to label them. Thanks to marketing campaigns, squelched state initiatives and a flood of GE products on the market, the public has largely adopted this belief as well.
 
Would it shock the public to know that the Food and Drug Administration (FDA) has never formally approved any GE crop as safe for human consumption? Instead, these companies have been trusted to self-regulate with little scientific oversight and even less transparency in their methods.

This was quietly mentioned in December 2014, during a testimony given by Michael Landa, former director of the Center for Food Safety and Applied Nutrition with the FDA, before the House Subcommittee on Health.

His testimony drew attention to a fact often overlooked in the ongoing debate around GE food safety: The FDA has exempted developers of genetically modified organisms (GMOs) from premarket reviews of their products, which would normally result in a formal assessment and either a rejection or approval of their safety for human consumption. Landa's testimony described the risk assessment process for GE crops, which continues to use a policy crafted in 1992, establishing that the FDA sees no essential difference between GE crops and their conventionally grown counterparts.

As a result, the FDA merely invites GE developers to voluntarily consult with the FDA on their products' safety.

According to an article written by William Freese and David Schubert on the FDA's risk assessment process:

Under voluntary consultation, the GE crop developer is encouraged, but not required, to consult with the FDA. The company submits data summaries of research it has conducted but not the full studies. That is, the FDA never sees the methodological details, but rather only limited data and the conclusions the company has drawn from its own research. As one might expect with a voluntary process, the FDA does not require the submission of data.

During his testimony, Landa offered assurance that:

The fact that participation in the process is voluntary should not mislead individuals to believe that the process does not provide for a rigorous food safety evaluation. It is not uncommon for FDA to request additional data and information or clarification about the data and information submitted by the developer.

Landa failed to mention that these requests are often refused or ignored, and when that happens the FDA continues its assessment without the additional data.

A study conducted by David Gurian-Sherman found that when the FDA requested additional information to conduct a complete and thorough safety assessment 50 percent of the time GE food developers "did not comply with that request."

The study goes on to show that of the developer data summaries they reviewed and that were submitted to the FDA, there were "obvious errors that were not identified by FDA during its review process," and the summaries "often lacked sufficient detail, such as necessary statistical analyses needed for an adequate safety evaluation."

Even more concerning, Gurian-Sherman revealed that these submissions to the FDA often did not evaluate dangerous compounds such as toxicants in tomatoes or anti-nutrients in corn and, "allergenicity testing was not always performed using the best tests available."
 
Alarmingly, Gurian-Sherman's study also reports that upon the FDA's completion of a review of corporate-generated data summaries, the FDA does not generate its own safety assessment, but merely summarizes for the public the developers' food-safety analyses.
 
None of the GE crops currently in the market place have ever been FDA approved as safe. As Freese and Schubert point out:

Instead, at the end of the consultation, the FDA merely issues a short note summarizing the review process and a letter that conveys the crop developer's assurances that the GE crop is substantially equivalent to its conventional counterpart.

The implication is made that there exists a rigorously tested, well-regulated marketplace of GE food. However, these risk assessments, when they occur at all, are highly questionable, and the ubiquity with which the FDA has issued these summaries of corporate-driven analyses of their own products only casts further doubt on their credibility and significance.

What's the problem?

A problem arises when independent researchers appeal to these risk assessments of GE crops, and their subsequent FDA "approval" as testaments to their inherent safety. Further problems occur when independent studies are conducted on various aspects of GMO and GE crop safety, but often after the products are already on the market.

Too often, the independent nature of these studies is dubious to begin with. Alison Van Eenennaam's recent literature review, for example, received a great deal of media attention, and though touted as independent, was sponsored by the Kellogg Company which spent $1 million fighting GMO labeling initiatives in California and Washington State in 2013.

The literature reviewed by Van Eenennaam was a collection of animal feeding studies, conducted by six researchers all of whom work with AgroParisTech, which considers Monsanto a business partner and sponsor of its research.

Such conflicts of interest call into question the "independent" nature of a lot of research done in the field. The lack of regulatory oversight indicates that the marketplace is not a well-regulated one, nor is it transparent in its risk assessment methods. Neither of these issues necessarily evidence that GE crops themselves are dangerous for consumption.

There is, however, an important distinction to be made between the safety of consuming GE crops and the safety of consuming the herbicides used in their cultivation. The FDA is only concerned with the GE crops themselves, while herbicide use is under the purview of the Environmental Protection Agency. Research on glyphosate-based herbicides is highly contested, with recent studies indicating glyphosate as potentially carcinogenic, potentially active in human cell-toxicity, and indicating its potential to damage DNA in humans and fish. A recent article in The Guardian indicates that there may be still further harmful side effects to these herbicides that remain unexamined. All of which only strengthen arguments in favor of thorough, independent safety assessments and labeling of GMO products in the marketplace.

Recommendations put forward in Gurian-Sherman's study are common sense: Congress should provide the FDA with legal authority for mandatory review and safety approval of GE crops. Additionally, the FDA should develop detailed safety standards and testing guidelines, and require developers to submit not summaries of data, but complete details about their testing methods, the actual data from safety tests and statistical analyses of those data. The FDA should then be prepared to reassess the safety of GE products if new safety concerns are recognized or new tests become available.

Landa made a point in his testimony to highlight that there is no need to label GE crops because they do not differ significantly from their conventional counterparts, and he sides with courts that have held that "consumer desire to know such information is not, by itself, sufficient to require such labeling." Perhaps if consumer desire to know is not sufficient in itself, these flawed, weak and blatantly toothless risk assessments provide a stronger basis to demand that GE food products be labeled until we have more thorough testing and review standards in place.

Besides, you can take it from Monsanto's director of corporate communications, Phil Angell, in his oft-quoted interview in The New York Times: "Monsanto should not have to vouchsafe the safety of biotech food," he said. "Our interest is in selling as much of it as possible. Assuring its safety is the FDA's job."

Copyright, Truthout. May not be reprinted without permission.

Alex James

Alex James is a critical scholar of science, culture and social policy. He has a MA in cultural translation from the American University of Paris, France, and a BA in political science from California State University, Sacramento.


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Eat at Your Own Risk: Flawed FDA Risk Assessments Strengthen Arguments for Labeling GMOs

Wednesday, 25 February 2015 09:19 By Alex James, Truthout | Op-Ed
  • font size decrease font size decrease font size increase font size increase font size
  • Print

Eat at Your Own Risk: Flawed FDA Risk Assessments Strengthen Arguments for Labeling GMOs(Image: Jared Rodriguez / Truthout)

Help Truthout keep publishing stories like this: They can’t be found in corporate media! Make a tax-deductible donation today.

For the past two decades, developers of genetically engineered (GE) crops and their corporate allies have maintained that because their products are so obviously safe, there is no need to label them. Thanks to marketing campaigns, squelched state initiatives and a flood of GE products on the market, the public has largely adopted this belief as well.
 
Would it shock the public to know that the Food and Drug Administration (FDA) has never formally approved any GE crop as safe for human consumption? Instead, these companies have been trusted to self-regulate with little scientific oversight and even less transparency in their methods.

This was quietly mentioned in December 2014, during a testimony given by Michael Landa, former director of the Center for Food Safety and Applied Nutrition with the FDA, before the House Subcommittee on Health.

His testimony drew attention to a fact often overlooked in the ongoing debate around GE food safety: The FDA has exempted developers of genetically modified organisms (GMOs) from premarket reviews of their products, which would normally result in a formal assessment and either a rejection or approval of their safety for human consumption. Landa's testimony described the risk assessment process for GE crops, which continues to use a policy crafted in 1992, establishing that the FDA sees no essential difference between GE crops and their conventionally grown counterparts.

As a result, the FDA merely invites GE developers to voluntarily consult with the FDA on their products' safety.

According to an article written by William Freese and David Schubert on the FDA's risk assessment process:

Under voluntary consultation, the GE crop developer is encouraged, but not required, to consult with the FDA. The company submits data summaries of research it has conducted but not the full studies. That is, the FDA never sees the methodological details, but rather only limited data and the conclusions the company has drawn from its own research. As one might expect with a voluntary process, the FDA does not require the submission of data.

During his testimony, Landa offered assurance that:

The fact that participation in the process is voluntary should not mislead individuals to believe that the process does not provide for a rigorous food safety evaluation. It is not uncommon for FDA to request additional data and information or clarification about the data and information submitted by the developer.

Landa failed to mention that these requests are often refused or ignored, and when that happens the FDA continues its assessment without the additional data.

A study conducted by David Gurian-Sherman found that when the FDA requested additional information to conduct a complete and thorough safety assessment 50 percent of the time GE food developers "did not comply with that request."

The study goes on to show that of the developer data summaries they reviewed and that were submitted to the FDA, there were "obvious errors that were not identified by FDA during its review process," and the summaries "often lacked sufficient detail, such as necessary statistical analyses needed for an adequate safety evaluation."

Even more concerning, Gurian-Sherman revealed that these submissions to the FDA often did not evaluate dangerous compounds such as toxicants in tomatoes or anti-nutrients in corn and, "allergenicity testing was not always performed using the best tests available."
 
Alarmingly, Gurian-Sherman's study also reports that upon the FDA's completion of a review of corporate-generated data summaries, the FDA does not generate its own safety assessment, but merely summarizes for the public the developers' food-safety analyses.
 
None of the GE crops currently in the market place have ever been FDA approved as safe. As Freese and Schubert point out:

Instead, at the end of the consultation, the FDA merely issues a short note summarizing the review process and a letter that conveys the crop developer's assurances that the GE crop is substantially equivalent to its conventional counterpart.

The implication is made that there exists a rigorously tested, well-regulated marketplace of GE food. However, these risk assessments, when they occur at all, are highly questionable, and the ubiquity with which the FDA has issued these summaries of corporate-driven analyses of their own products only casts further doubt on their credibility and significance.

What's the problem?

A problem arises when independent researchers appeal to these risk assessments of GE crops, and their subsequent FDA "approval" as testaments to their inherent safety. Further problems occur when independent studies are conducted on various aspects of GMO and GE crop safety, but often after the products are already on the market.

Too often, the independent nature of these studies is dubious to begin with. Alison Van Eenennaam's recent literature review, for example, received a great deal of media attention, and though touted as independent, was sponsored by the Kellogg Company which spent $1 million fighting GMO labeling initiatives in California and Washington State in 2013.

The literature reviewed by Van Eenennaam was a collection of animal feeding studies, conducted by six researchers all of whom work with AgroParisTech, which considers Monsanto a business partner and sponsor of its research.

Such conflicts of interest call into question the "independent" nature of a lot of research done in the field. The lack of regulatory oversight indicates that the marketplace is not a well-regulated one, nor is it transparent in its risk assessment methods. Neither of these issues necessarily evidence that GE crops themselves are dangerous for consumption.

There is, however, an important distinction to be made between the safety of consuming GE crops and the safety of consuming the herbicides used in their cultivation. The FDA is only concerned with the GE crops themselves, while herbicide use is under the purview of the Environmental Protection Agency. Research on glyphosate-based herbicides is highly contested, with recent studies indicating glyphosate as potentially carcinogenic, potentially active in human cell-toxicity, and indicating its potential to damage DNA in humans and fish. A recent article in The Guardian indicates that there may be still further harmful side effects to these herbicides that remain unexamined. All of which only strengthen arguments in favor of thorough, independent safety assessments and labeling of GMO products in the marketplace.

Recommendations put forward in Gurian-Sherman's study are common sense: Congress should provide the FDA with legal authority for mandatory review and safety approval of GE crops. Additionally, the FDA should develop detailed safety standards and testing guidelines, and require developers to submit not summaries of data, but complete details about their testing methods, the actual data from safety tests and statistical analyses of those data. The FDA should then be prepared to reassess the safety of GE products if new safety concerns are recognized or new tests become available.

Landa made a point in his testimony to highlight that there is no need to label GE crops because they do not differ significantly from their conventional counterparts, and he sides with courts that have held that "consumer desire to know such information is not, by itself, sufficient to require such labeling." Perhaps if consumer desire to know is not sufficient in itself, these flawed, weak and blatantly toothless risk assessments provide a stronger basis to demand that GE food products be labeled until we have more thorough testing and review standards in place.

Besides, you can take it from Monsanto's director of corporate communications, Phil Angell, in his oft-quoted interview in The New York Times: "Monsanto should not have to vouchsafe the safety of biotech food," he said. "Our interest is in selling as much of it as possible. Assuring its safety is the FDA's job."

Copyright, Truthout. May not be reprinted without permission.

Alex James

Alex James is a critical scholar of science, culture and social policy. He has a MA in cultural translation from the American University of Paris, France, and a BA in political science from California State University, Sacramento.


Hide Comments

blog comments powered by Disqus