Tamar Haspel's picture
One of the reasons for skepticism of assertions of GMO safety is that any negative results from safety trials can simply go unpublished. To what extent has that happened, and will you support full disclosure of all results?

A:Expert Answer

We will not cut corners on safety and are committed to full disclosure of scientific research related to the health and safety of GM seeds.  We are also required by law to provide information that is not favorable to our products.  In submitting food safety information to the government for review, we cannot and would not pick and choose which research to present.

 

During the development of a new GM seed, much of the research is conducted by independent third-party laboratories certified to conduct safety testing using protocols required by the government. If a study were ever to yield a result that raised any food safety concern, we are required to present that information to the FDA. We take this requirement very seriously. Failure to provide such statements to the government is a crime.

Please see the relevant legal requirements at the end of this answer for each of the agencies (FDA, USDA, EPA) that have regulatory authority over GM seeds.  

USDA regulations (7CFR340.6) include the following statement regarding submissions (petitions):

 

  • A person shall also include information known to the petitioner  which would be unfavorable to a petition. If a person is not  aware of any unfavorable information, the petition should state,  “Unfavorable information: NONE.”
  • "The undersigned certifies, that to the best knowledge and  belief of the undersigned, this petition includes all information  and views on which to base a determination, and that it includes  relevant data and information known to the petitioner which  are unfavorable to the petition.”

 

EPA has a provision of FIFRA terms 6(a)2, Adverse Event Reporting, that requires registrants to report any harmful or adverse effects of registered products. Read more here.
 
The FDA also includes the following language in its letter inquiries letters to throughout consultation process:
 

“Based on the information [insert company name] has presented to FDA, we have no further questions concerning food ingredients derived from [product name] and feed derived from [product name]. However, as you are aware, it is [company name] continuing responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.”


For more detailed information:  

 

Technology providers have obligations under federal law to disclose adverse effects involving their GMO products. In their petitions for the regulatory authorizations needed to commercialize a GMO product (i.e., deregulation), companies are obligated to disclose any such adverse effects (cf., 7 CFR 340.6 (A)). Additionally, companies are obligated under the Federal Insecticide, Rodenticide and Fungicide Act, which regulates pesticides, including pesticides expressed in insect-resistant crops, to promptly disclose adverse effects related to these products, regardless whether the effects were noted in safety testing or in experience with the in-plant pesticide in the field (cf., FIFRA 6(a)(a)(2)). Failure to disclose information about adverse effects to the relevant authorities, whether deliberate or unintentional, may not only jeopardize product approvals but also be punishable by significant fines. Still more damaging, however, would be the loss of confidence that failure to report would create for a technology provider with the regulators who control authorizations for its current and future products. Finally, given the time and cost involved in bringing a new GMO technology to the market (estimated time and costs are more than 10 years and $135 million), technology providers must take a long-range view of their business to remain competitive in their industry and cannot afford to invest in products that will not meet regulatory hurdles or that will prove unsustainable in the marketplace due to subsequent concerns about risk. These dynamics create powerful, built-in motivators for rigorous attention to product safety, transparent dialogue with external stakeholders, collaboration with third party researchers and continuing improvements in product stewardship. Companies failing in their commitment to these prerequisites will not survive in the present regulatory and social environment.

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Comments

greekmiss's picture

I too have this concern as I found an article some time ago that indicated that outside testing of GMO safety is actually not allowed unless pre-approved by the GMO companies themselves.

jtrav21's picture

@greekmiss - This is no longer the case, and has not been for years. Major seed companies provide standard research agreements for universities or other research groups to conduct studies using patented GMO technologies.

Check this info out: http://www.monsanto.com/newsviews/Pages/public-research-agreements.aspx

Seeds of Death's picture

Your answer is just spin. You are giving us a Monsanto link? And after the research is conducted, even with freedom of operation, who controls the release and publication of results?

jtrav21's picture

@Seeds of Death - the fact is that GMO seeds can be used for independent testing, per the comment from greekmiss. Did you read the details, or simply react to the name Monsanto? Maybe you can answer your own question and share some additional facts with us?

achood4mu's picture

@Seeds of Death - the question was about the companies' philosophy for approval of GMO testing. Why wouldn't an appropriate answer be from one of the company's websites??

Tamar Haspel's picture

jtrav21, I'm very familiar with Monsanto's policy. But the original question is about in-house research, some of which is done before the seed is available to anyone, including the academic institutions covered in the agreements.

Have negative results been withheld, and will the industry commit to full disclosure. The pharmaceutical industry is being asked to do the same.

Ben Schaefer's picture

I don't think they are withheld, they are just not advanced. There are hundreds of different combinations of sequences tested every year. Only a few go forward, there is no further testing on any that are not going to be commercialized.

Tamar Haspel's picture

Ben, I don't think research on products never brought to market is the issue here. It's transparency on products that are brought to market.

Cornlover's picture

And the black helicopters are following you to.

KIWIHEALTH's picture

I fail to see the need or benefits of GMO technology. The studies, that seem often quashed or ignored that show rats with tumors, with reproductive issues, cows miscarrying at high high rates due to GMO corn in their feed etc. Super weeds, farmers killing themselves as their farms collapse as the GMO crops suck the life out of the soil. Contamination of non GMO that is seemingly unavoidable and results in a complete lack of freedom of choice for a consumer. As it can't be contained there is nothing safe in my view. Why not label foods without threatening lawsuits to states and countries? Why bully countries to accept something they do not want to accept? Why use strong arm tactics and manipulate the political system to gain advantage in international negotiations? Such as is the situation that seems to be a-brewing with Europe right now. Behind closed doors! There is not an ounce of additional information that will sway me from my right to choose that is being taken away from me or for me to believe in the slightest that GMO products are safe and worth the risk. Why are we playing God? This is not about education this is again about manipulation of the public. A propaganda site at its best. I pray to God that this fails to con anyone into believing that GMO is the way of the future and that it is safe. Every week something else comes out about how its not. But instead of stopping and checking, there is way too much money at stake for these companies to allow them to be proven unsafe. For the companies to lose their market share. If they can't convince the public that its safe then what do you think happens to their share price? Those living in luxury have somewhat of an agenda here. Protect their bank accounts and their riches. its nothing to do with safety of products now and everything to do with the bottom line. They are screwed if this proves legally, which heaven knows it should have already, to be a terrible terrible science experiment. There is nothing for them to lose by trying to con the world into thinking its safe and everything financial to gain. They are not interested in helping the world. They made a mistake and they can't now admit it like mature adults. The sad thing is that the joke will be on them at the end of the day. Or.. are they not even eating their own GMO produce themselves? Perhaps we can study them before we become their real live study

Cornlover's picture

Kiwi health there is so much wrong in your post I don't think I can help you understand.

Grace Joubarne's picture

Even as a child we knew that when a person acts like they are tricking us, and they stand to gain big time if they succeed, then we are not only sceptical, but resistant to their efforts. Now that the most esteemed independent scientists and researchers in the world have revealed the horrors caused by GMOs, I believe that Monsanto's persistence in trying to force us to accept GMO will only cause violence and revolution against them in the end. Many people today recognize that companies who were involved in the great holocaust, such as Bayer and companies such as Monsanto who are known for their DDT, Agent Orange, Sarin gas etc can hardly be in a position to provide nutrition to the masses. Poison yes, nutrition, not possible.

Doug Huffman's picture

Where would the deniers expect to find freely accessible research publications/sites?

I am particularly interested in physics and emerging diseases, publicly accessible academic papers is a challenge even in non-controversial fields.

Cornlover's picture

There has been no lagit proof against.

Ben Schaefer's picture

If there was something negative with the product, it would never be advanced to commericalization.

Tamar Haspel's picture

Ben, I suspect that's true a lot of the time. But I don't think it's unreasonable to ask for transparency on health research done on products we eat. I think both tobacco and pharmaceuticals have set examples that justify a little public suspicion, and full disclosure would mean one fewer unknown. Since much of GMO opposition is about what we don't know, I think that would be a good thing.

Ban_All_GMO's picture

I guarantee to you that any negative results have been glossed over or dismissed/not published. Just look at all their "scientific studies" on fluorosilicic acid, "studies" that claim that the industrial waste is safe to drink even if it isn't safe to dump in the environment.
Their "studies" prove whatever the highest bidder wants them to prove.

Kiya Tabb's picture

Ben works for Monsanto. Let's put that in perspective first.

Cornlover's picture

Why are you antis here of you are not going to believe anything they say and then call them liers,how rude

Tamar Haspel's picture

Thank you for such a thorough answer. I really appreciate your clear explanation, and links to the legal sources.

rickspalding's picture

Oh yes this is perfectly clear by the laws that must be followed. Just like the unauthorized wheat field in Oregon. What a bunch of BS. Plausible deniability, simple as that. If you repeat something enough, morons will believe it at some point. Just like GMO is necessary to feed the world. That is a major fallacy.

Cornlover's picture

rickspalding you don't have a clue of what happened in Oregon and any study done has to give up results,that's the law.

achood4mu's picture

@rickspalding -Your comments are not constructive. It is clear that you know nothing about the RR Wheat incident in Oregon and that you know little about the law. Could you please try to be open to discussion rather than just spouting out the anti-GMO talking points? Thanks!

Chris123's picture

For true answers:
Evidence-based examination of the claims made for the safety and efficacy of genetically modified crops: www.gmo-news.com/2013/07/gmo-myths-and-truths/

as pdf download.

Johann Doyle's picture

Why not allow labeling if there is nothing unhealthy in your products?

The medical evidence on the blood toxicity caused by consuming certain gmo's shows that science knew about the toxicity of bt toxins years ago.

http://www.greenmedinfo.com/blog/new-study-proves-bt-toxins-gmos-toxic-m...

As a mammal, I need to say that I don't think you should be marketing another bio poison.

It won't matter much if your spin doctors go crazy on my post. This information isn't mine. It's available on 1000's of sites and there are research labs everywhere continuing to research the science.

What I really wanted to say was that the cat is out of the bag. It is only a matter of time before a majority of the world is going to know what you are doing with gmo's. It is difficult to boycott all the products that you guys fiddle with, but when the health issues are proven...the law suits will start. Then things will get interesting.

http://www.exposingthetruth.co/spliced-gmo-genes/#axzz2ccg0YpUq

It's really too bad that you're using your scientific abilities to produce toxic food. What were you thinking?

Regards,

jd