by Allison Wilson, PhD and Jonathan Latham, PhD
The biotech industry and its supporters have promoted GMO Golden Rice for decades as an urgently needed solution to vitamin A deficiency.
But, in a surprising twist, the US Food and Drug Administration (FDA) has concluded its consultation process on Golden Rice by informing its current developers, the International Rice Research Institute (IRRI), that Golden Rice does not meet the nutritional requirements to make a health claim.
Golden Rice refers to GMO rice plants modified to produce beta-carotene (also called provitamin A) in their grain. This latest version of Golden Rice contains three added genes. Two specify enzymes in the β-carotene biosynthesis pathway, and are taken from bacteria and maize. The third specifies a (non-antibiotic) selectable marker protein used in the modification process (Paine et al. 2005).
First described in the scientific literature over 18 years ago by public sector researchers (Ye et al. 2000), various public and private sector iterations of Golden Rice have subsequently been produced (Bollenidi et al. 2014). These represent repeated efforts to increase beta-carotene levels, while still maintaining plant vigor and yield.
The Golden Rice version submitted to FDA by IRRI, called event GR2E, is the only Golden Rice to have ever been submitted for regulatory approval. In 2017, it was approved for import by regulators in Australia, New Zealand, and Canada. Originally developed by Syngenta, Golden Rice GR2E is now funded by the Gates Foundation.
The letter containing FDA’s statement on GR2E’s lack of nutritional benefit was posted on May 25th, 2018 (FDA 2018b).
In IRRI’s consultation with FDA, IRRI stated it has no intention of marketing Golden Rice in the US. Nevertheless, in part because rice is wind pollinated, it is expected that, if commercialized, Golden Rice GR2E will contaminate U.S. rice imports.
Since 1996, when they were first grown commercially, many hundreds of GMO contamination events have been documented (Price and Cotter, 2014). This includes contamination by an unreleased GMO rice that led to a massive disruption of the global rice market in 2006-08. Hence the need to consult with US and other national authorities.
As is standard for GMO foods (since FDA has no legal powers to approve or reject them) FDA has responded to IRRI’s consultation request, which is voluntary, by noting that its maker has concluded that Golden Rice is safe (Pelletier 2006). Thus FDA’s letter states:
“Based on the safety and nutritional assessment IRRI has conducted, it is our understanding the IRRI concludes that human and animal food from GR2E rice is not materially different in composition, safety, or other relevant parameters from rice-derived food currently on the market except for the intended beta-carotene change in GR2E rice.“
But the letter from FDA goes further. It asserts that:
“the concentration of β-carotene in GR2E rice is too low to warrant a nutrient content claim.“
In an attached memo, FDA notes the beta-carotene content of unmilled Golden Rice GR2E ranged from 0.50-2.35ug/g (FDA 2018a). That is, beta-carotene levels in Golden Rice are both low and variable. This compares to beta-carotene levels measured in non-GMO foods such as fresh carrot (13.8-49.3ug/g; Schaub et al. 2017); Asian greens (19.74-66.04 ug/g; Chandra-Hioe et al. 2017); and spinach (111ug/g; Li et al. 2017).
FDA notes the mean value of beta-carotene for GR2E is 1.26ug/g. This is, paradoxically, less beta-carotene than the 1.6ug/g measured for the original iteration of Golden Rice (Ye et al. 2000).
Greenpeace once calculated that such low levels would necessitate a person to eat 3.75 kg of Golden Rice per day to receive an adequate amount of beta-carotene.
Rapid Degradation of β-carotene in Golden Rice
In the same memo, FDA also states,
“IRRI acknowledged that it expects the actual dietary intakes to be lower given …that β-carotene levels in food containing GR2E rice would decline over time due to storage…”
Degradation of beta-carotene during storage is a problem that may prove even more troublesome for the proposed nutritional benefits of Golden Rice than its initial low levels.
Unnoticed by the media, a 2017 paper published in the Journal of Agricultural and Food Chemistry reported that the beta-carotene content of Golden Rice GR2E at harvest is short-lived (Schaub et al. 2017).
This study found Golden Rice retained only 60% of its original beta-carotene levels after 3 weeks of storage and just 13% after 10 weeks.
The apparent explanation is that the beta-carotene in Golden Rice is unstable in the presence of oxygen. Thus, under normal storage conditions, the beta-carotene in Golden Rice grains will rapidly degrade.
Under tropical farming, storage, and household conditions, degradation may be faster still.
In any event, the low levels and rapid degradation of beta-carotene measured in Golden Rice GR2E seem a significant blow to the likelihood that Golden Rice will fulfill expectations. That is, remedy Vitamin A deficiencies in malnourished and impoverished people, in countries like the Philippines and Bangladesh (Stone and Glover 2016; Hilbeck and Herren 2016).
Reports of Higher Levels of β-carotene
Higher levels of beta-carotene have nevertheless sometimes been reported for Golden Rice GR2E (e.g. FSANZ 2017; Schaub et al. 2017; Paine et al. 2005). For example, the second FDA memo notes mean beta-carotene levels in milled rice from the same experiment were 3.57ug/g. Schaub et al. (2007) reported 31.1ug/g at the start of their degradation study.
All the higher levels are explained by some combination of the following: measurement of total carotenoids rather than beta-carotene alone; milling the rice; use of non-AOAC (Association of Official Analytical Chemists) extraction methods; differences in genetic backgrounds (e.g. Schaub et al. 2017 use GR2E Kaybonnet, which is unsuitable for the Philippines); growth under greenhouse rather than field conditions; and/or differences in field environments or growing seasons. In other words, the low levels communicated to FDA seem to be the most accurate and realistic.
Is Golden Rice GR2E Safe?
Despite FDA’s letter, the biosafety of Golden Rice GR2E is contested. Testbiotech and other researchers have pointed out that key human safety and efficacy studies are lacking, especially for target populations (Then and Bauer-Panskus 2018; Stone and Glover 2016; Schubert 2008). Specific health concerns include unintended nutritional effects of carotenoid biosynthesis or its degradation products and because certain components of the carotenoid pathway can be toxic (Schubert 2008; Stone and Glover 2016).
Also of interest is that FDA’s assessment of GR2E safety was based on estimated annual U.S. per capita rice consumption of 11.8kg. Annual consumption in the Philippines averages over 110kg (Muthayya et al. 2014).
In 2017, IRRI/PhilRice submitted to the Philippine Department of Agriculture an application for the production and testing of Golden Rice GR2E. It has yet to be granted.
References
Bollinedi, et al. (2014). Marker Assisted Biofortification of Rice with Pro-vitamin A Using Transgenic Golden Rice Lines: Progress and Prospects. Indian Journal of Genetics, 74(4), 624-630. Available at: http://www.indianjournals.com/ijor.aspX?target=ijor:ijgpb&volume=74&issue=4s&article=016
Chandra-Hioe et al. (2017) Lutein and β-Carotene in Selected Asian Leafy Vegetables. J Food Chem Nanotechol, 3(3), pp.93-97. Available at: http://unitedscientificgroup.com/journals/ets/articles/v1n1/jfcn-043-maria-chandra-hioe.pdf
FDA (2018a) GR2E Biotechnology Notification File No. 000158 Note to the File Date: May 8, 2018. Available at: https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GEPlants/Submissions/ucm607450.pdf
FDA (2018b) GR2E Response Letter RE: Biotechnology Notification File No. BNF 000158 Available at: https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GEPlants/Submissions/ucm608797.pdf
FSANZ (2017) Supporting Document 1. Safety Assessment Report (at Approval) – Application A1138. Food Derived from Provitamin A Rice Line GR2E. Available at: http://www.foodstandards.gov.au/code/applications/Documents/A1138_SD1_at approval.pdf
Hilbeck, A. and H. Herren (2016) Millions Spent, No One Served: Who Is to Blame for the Failure of GMO Golden Rice? Independent Science News: Available at:
https://www.independentsciencenews.org/health/millions-spent-who-is-to-blame-failure-gmo-golden-rice/
Li et al. (2017) Selected Nutrient Analyses of Fresh, Fresh-Stored, and Frozen Fruits and Vegetables. Journal of Food Composition and Analysis, 59, 8-17. Available at: http://www.frozenfoodfacts.org/assets-foundation/misc/images/JFCA%20Frozen%20Food%202017.pdf
Muthayya, S. et al. (2014) An Overview of Global Rice Production, Supply, Trade, and Consumption. Annals of the New York Academy of Sciences, 1324(1), pp.7-14. Available at: https://nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.12540
Paine, Jacqueline A., et al. (2005) Improving the Nutritional Value of Golden Rice Through Increased Pro-Vitamin A Content. Nature Biotechnology 23.4: 482. Available at: http://eprints.icrisat.ac.in/210/1/NatureBiot23_482-487_2005.pdf
Pelletier, David L. (2006) FDA’s Regulation of Genetically Engineered Foods: Scientific, Legal and Political Dimensions. Food policy 31.6: 570-591. Available at: https://www.independentsciencenews.org/wp-content/uploads/2014/01/Pelletier-2006-Scienti%EF%AC%81c-legal-and-political-dimensions-.pdf
Price, Becky, and Janet Cotter. (2014) The GM Contamination Register: a Review of Recorded Contamination Incidents Associated with Genetically Modified Organisms (GMOs), 1997–2013. International Journal of Food Contamination 1.1: 5. Available at: https://foodcontaminationjournal.springeropen.com/articles/10.1186/s40550-014-0005-8
Schaub, Patrick, et al. (2017) Nonenzymatic β-Carotene Degradation in Provitamin A-Biofortified Crop Plants. Journal of Agricultural and Food Chemistry 65.31: 6588-6598. Available at: https://www.gefree.org.nz/assets/pdf/2017-carotene-degradation.pdf
Schubert, David R. “The problem with nutritionally enhanced plants.” Journal of medicinal food 11.4 (2008): 601-605. Available at: https://www.stopogm.net/sites/stopogm.net/files/NutritionallyEnhancedPlants.pdf
Stone, G. D., & Glover, D. (2016) Disembedding Grain: Golden Rice, the Green Revolution, and Heirloom Seeds in the Philippines. Agriculture and Human Values, 34(1): 87-102. Available at: http://pages.wustl.edu/files/pages/imce/stone/stone_glover_2016_golden_rice.pdf
Then and Bauer-Panskus (2018) Testbiotech on Risk Assessment for Golden Rice by FSANZ February 2018. Available at: https://www.testbiotech.org/en/publikationen
Ye, Xudong, et al. (2000) Engineering the Provitamin A (β-carotene) Biosynthetic Pathway into (Carotenoid-Free) Rice Endosperm. Science 287.5451: 303-305. Available at: http://www.uniroma2.it/didattica/FisiolBiotecVeg/deposito/Golden_rice_.Ye_et_al..pdf
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Comments from Adrian Dubock
Sent as pdf files
https://www.independentsciencenews.org/wp-content/uploads/2018/06/Letter-to-Dr-Latham-about-US-FDA-and-Health-Canada-Registration-of-Golden-Rice-GR2E-signed.pdf
Plus the two attachments referred to:
1) https://www.independentsciencenews.org/wp-content/uploads/2018/06/Highlighted-US-FDA-GR2E-May-24-2018-Biotechnology-Consultation-Agency-Response-Letter-BNF-000158.pdf
2) https://www.independentsciencenews.org/wp-content/uploads/2018/06/Highlighted-GR2E-Golden-Rice-Canada-16-March-2018-Novel-Food-Information-Provitamin-A-Biofortified-Rice.pdf
Adrian Dubock (PhD.)
Board Member & Executive Secretary,
Golden Rice Humanitarian Board.
http://www.goldenrice.org
Reply to Adrian Dubock’s letter about Golden Rice:
1.FDA’s decision: In the documents they made available to the public, FDA said that Golden Rice did not warrant a nutritional content label. However, they did not say how they came to their conclusion. Nevertheless, anyone looking at the data on beta-carotene levels and degradation in GR2E can come to their own conclusion that nutritional claims are not merited.
2.Beta-carotene to Vitamin A conversion ration: Dubock references Tang et al. 2010 when he claims that Golden Rice has the most efficient beta-carotene to Vitamin A conversion ratio. However that conversion number originates from Tang et al. 2009. The Tang et al. 2009 study was carried out on healthy adults given rice from hydroponically gown Golden Rice (whose event name was not specified and no measurements of starting levels of beta-carotene were given). After harvest, this rice was kept at either -20 or –80C degrees. The study subjects were healthy US adults, with a normal diet, given an additional 10g butter with their rice. In other words, the study is unlikely to be relevant to the targeted population for GR2E Golden Rice (i.e. children or pregnant mothers who are malnourished, have a poor diet, and likely have other diseases or parasite infections).
3.Dubock states “with adults (in the USA)and most importantly children (in China), careful and sophisticated research has shown that the beta-carotene in GR, following only a single meal, is very efficiently converted to vitamin A by the human body.” Dubock provides no reference for this statement. However, in addition to the Tang et al. 2009 study critiqued above, there is a Tang et al. 2012 study often cited for GR benefits and efficacy. This 2012 study was carried out on Chinese school children but was retracted for ethical violations (parents were not adequately informed of the study). However the same scientific critiques can be made as for the original US adult study by Tang et al. in 2009: This study was carried out on healthy school children with a good diet (including meat and egg for example, and other fruit and veg). Children were either free of parasites or treated to be free of parasites before the study. GR was grown and stored in the same way as in the previous study and no specific GR event was named. A good diet was given in addition to the GR during the study period. Therefore this study does not address uptake or conversion in the targeted population, nor does it address real world levels of beta-carotene in GR2E grown in a realistic production scenario for the target populations.
4.Dubock claims that GR2E yield is the same as the wild type of the same Indica cultivar: The reference given by Dubock provides no yield data for GR. It is his three page review of the possibilities of biofortification and efforts to improve yield. The paper states it is possible to biofortify a plant and also have it give high yields. But it provides no data (or links to data) that shows this has been achieved for GR.
References discussed in Dubock letter:
Tang, Guangwen, et al. “Golden Rice is an effective source of vitamin A–.” The American journal of clinical nutrition 89.6 (2009): 1776-1783.
Tang, Guangwen, et al. “β-Carotene in Golden Rice is as good as β-carotene in oil at providing vitamin A to children–.” The American journal of clinical nutrition 96.3 (2012): 658-664. (RETRACTED)
Tang, Guangwen. “Bioconversion of dietary provitamin A carotenoids to vitamin A in humans–.” The American journal of clinical nutrition 91.5 (2010): 1468S-1473S.
Dubock, Adrian. “An overview of agriculture, nutrition and fortification, supplementation and biofortification: Golden Rice as an example for enhancing micronutrient intake.” Agriculture & Food Security 6.1 (2017): 59.
[RESEND of Comment not accepted on earlier attempt.]
On June 4, the date of the posting of this story, I wrote Dr. Dennis M. Keefe, author of the FDA’s approval letter, asking him to clarify this statement that the beta carotene level in GR2E was too low to warrant a nutritional comment claim. Here is the FDA response for the record, received June 7:
Hello Ed,
Below please find our response to your question.
It is unfortunate that the statement you reference in our letter responding to BNF 158 has been misconstrued to suggest that there would be no value of the pro-vitamin A in golden rice for its use in the countries where it is intended for distribution.
Our statement applies only to labeling considerations in the United States, in that golden rice contains insufficient pro-vitamin A to warrant differential labeling for nutrient content based on the low levels of rice consumption in the U.S. Requirements for nutrient content claims on labels in the United States take two factors into account, the amount of the nutrient needed as well as it’s concentration in the food and the typical or average level of that food consumed in the U.S. For the rice to be labeled in the United States with a claim containing provitamin A, our regulations stipulate that the food must contain 10-19 percent of the RDI or DRV for the substance per reference amount customarily consumed (essentially a measure of consumption).
Additionally, U.S. consumers eat rice at very low levels compared to consumers in the specific Asian countries with vitamin A deficiency for which golden rice was developed. IRRI reports that consumption of rice by children in Bangladesh is 12.5 g/kg body weight/day, compared to about 0.5 g/kg bw/d for U.S. consumers). Rice is the major staple in those countries and levels of rice consumption are many-fold higher than they are in the U.S. While a U.S Consumer would be unlikely to eat enough of the rice to achieve that value (10-19 % of the NDI or RDA), that does not mean that the level of consumption of golden rice in the targeted countries would be insufficient to accomplish the intended effect of supplementing their very low consumption of vitamin A-containing foods. Consuming rice containing the levels of pro-vitamin A in GR2E rice as a staple of the diet could have a significant public health impact in populations that suffer from vitamin A deficiency.
Many thanks,
Marianna
Marianna Naum, Ph.D.
Team Lead, Strategic Communications
Strategic Communications and Public Engagement Staff
Office of Foods and Veterinary Medicine
U.S. Food and Drug Administration
5001 Campus Drive, College Park, MD 20740, HFS-315
Phone: 240-402-2748
Cell: 240-731-0262
Follow us on Twitter @FDAfood; @FDACosmetics; and @FDAanimalhealth
So says Martha from “STRATEGIC COMMUNICATIONS”. I had no idea that strategic communications was a scientific discipline, nor an FDA priority. But apparently they are. More seriously, it should be pointed out that since FDA is approving this rice based on a small per capita rice consumption, i.e.about 10% of what people eat in the Philippines, that its safety advice should be similarly qualified. You can’t have it both ways, Ed.-Jonathan
“You can’t have it both ways, Ed.” Me? I said nothing, one way or the other way, much less both ways. I simply reported what the FDA has now said on the record about your claim that the FDA says that the rice offers no nutritional benefits. It doesn’t say that and it has never said that. That claim is contradicted by your story, and now by the FDA itself in as many words. Under the circumstances, the respectable course of action is for you and Allison to retract your story. Do I expect that to happen? Not in my lifetime.
ED,
How can we retract IRRI’s own GR2E beta-carotene data, FDA’s own words, and Schaub et al.’s 2017 GR2E rice degradation studies? Are you questioning their data?
Here Marion Nestle explains FDA’s nutrient content claim: https://www.foodpolitics.com/2018/06/fda-says-golden-rice-does-not-contain-enough-beta-carotene-to-merit-a-health-claim/
She points out:
“*What does “too low to warrant a nutrient content claim” mean?
The FDA’s rules for nutrient content claims (go to pages 91 and 92) say:
“High,” “Rich in,” or “Excellent source of” means that a standard food portion contains 20% or more of the daily value for that nutrient.
“Good source,” “Contains,” or “Provides” means 10% to 19% of the daily value per standard serving.
“More,” “Fortified,” “Enriched,” “Added,” “Extra,” or “Plus” means 10% or more of the daily value than an appropriate reference food.
The daily value for beta-carotene is complicated because it is a precursor of vitamin A; 12 micrograms of beta-carotene are equivalent to one vitamin A unit. The standard for adults and children is 900 vitamin A units or 900 x 12 for beta-carotene = 10,800 micrograms.
One serving of Golden Rice must provide less than 10% of that amount (1,080 micrograms).
For comparison, one small carrot provides about 4000 micrograms of beta-carotene.”
***
Thus the low levels of beta-carotene in GR2E that IRRI reported to FDA do not merit a nutrient content claim according to the above FDA rules outlined by Marion Nestle. These are based on the amount of beta-carotene estimated to be present in one serving of GR2E.
FDA also notes in its memo: “IRRI acknowledged that it expects the actual dietary intakes to be lower given (1) that it is unlikely that all rice in the diet would be substituted with GR2E rice and (2) that beta-carotene levels in food containing GR2E rice would decline over time due to storage, processing, and cooking.”
Therefore, anyone actually wishing to eat Golden Rice GR2E to increase their consumption of beta-carotene would want to know how much beta-carotene was left by the time they purchased, cooked, and consumed the GR2E — and if they needed to consume fat while eating the rice, and if so how much, for the remaining beta-carotene to be absorbed. A lot of complicated calculations for so little, if any, beta-carotene.
I give up. I’ll be dealing with this whole episode elsewhere, in other media, not here.
i honesly agree with ed he is a lad
I think also it is clear that these approvals (Canada, Australia/New Zealand; USA), which IRRI is now boasting about on its website, are really to pressure the Philippines and Bangladesh to approve GMO Golden Rice. Since the normal course of GMO approval events is to approve in the home country(s) first (where it will be grown) and then to obtain approval abroad (where it might be consumed or contaminate exports), and only then to release the crop and sell its seeds to farmers. This sequence of events prevents foreign countries from approving crops that then are never actually grown or permitted and thereby wasting their time and public money. But it also prevents farmers in the growing country from planting varieties they cannot sell because they are not approved abroad. IRRI has gone about its business backwards and it’s not hard to speculate why.
Golden rice is not a scientific solution. We should be encouraging people to eat a diverse diet as so many other foods have so much more vitamin A. I want to know how Agribusiness is profiting from this.
John D – As you many know, many believe that Golden Rice was never intended to be a scientific solution to a nutritional problem — rather it was a political and PR solution to various corporate problems http://www.panna.org/blog/golden-rice-or-trojan-horse. It was not a solution supported or asked for by farmers or Vitamin A nutrition experts.
Before the biotech industry shills running the FDA cause more damage they need to be stopped! The food hunger initiative to end vitamin A deficiency by giving these poor people a diverse source of vitamin A, this is an absolute outright better solution.
Such a lack considerations for the consequences of making a GMO rice and not testing it in humans is wrong. Rigorous testing with animals over generations is necessary. It’s all for waste and public money. Farmers have no Problems growing plenty of carrots at home to feed our friends and family.
if there was data to support the safety and the nutrition of this Franken rice where is it? These corporate SOBs will start rearranging genes and they expect not to have issues with health?
Farming organically for high quality nutrient-dense organic produce is our solutions, not chemicals intensive ag. Reducing the need for global 1% elites to further control the food supply. This is what Franken rice is doing here. Its ALL ABOUT CONTROL of the global trade of food. We are letting corporations treat us like labrats in the process. Utter environmental destruction with genetic pollution of rice is unethical for contaminating such an important crop. Doubt can be a good thing in these cases and I wish these Rich countries had some.
Thanks!
OFD –Thank you for that important point — Doubt can be a good thing. It does seem that many biotechnologists – and biotechnology’s corporate, media, and academic proponents – have decided that biotechnology is a universally good thing, it is safe, and it is the solution to every problem. Not a very scientific conclusion, as the data on Golden Rice and other GMOs are constantly reminding us and as many scientists themselves have pointed out: https://link.springer.com/article/10.1186/s12302-014-0034-1
And Einstein too: “The important thing is not to stop questioning.”
Since you have essentially accused the government of my country, Canada, as somehow conspiring to pressure the governments of the Philippines and Bangladesh into adopting a rice which they are developing themselves, you should put the statement of Canada Health on record here. Note that Health Canada did not evaluate Golden Rice on the basis of nutritional value as per consumption in Canada:
Provitamin A Biofortified Rice Event GR2E (Golden Rice)
In 2017, Health Canada received a submission to allow the sale of a variety of rice, called Provitamin A Biofortified Rice Event GR2E (Golden Rice). This genetically modified rice variety has higher levels of provitamin A and is intended to be sold in countries where diets are typically low in vitamin A. GR2E rice will be grown commercially in major rice-producing regions, primarily in Asia. The International Rice Research Institute (IRRI) has indicated that this product is not intended to be sold in Canada at this time.
In order to determine whether this rice variety could be sold in Canada as food, the scientists at Health Canada conducted a scientific assessment that ensured that GR2E rice is safe for consumption, that the increased provitamin A levels posed no risk to Canadian consumers, and that it still had all its nutritional value. Our scientists also needed to assess how GR2E was developed and whether it can be toxic or cause allergic reactions. The ability of the GR2E rice in helping vitamin A deficiency in affected populations was not evaluated.
Scientists with expertise in molecular biology, microbiology, toxicology, chemistry and nutrition conducted a thorough analysis of the data and the protocols provided by the applicant to ensure the validity of the results.
Following this assessment, it was determined that the changes made in this rice variety did not pose a greater risk to human health than rice varieties currently available on the Canadian market. In addition, Health Canada also concluded that GR2E would have no impact on allergies and that there were no differences in the nutritional value of GR2E compared to other traditional rice varieties available for consumption except for increased levels of provitamin A.
Health Canada’s assessment of GR2E was conducted according to the Guidelines for Safety Assessment of Novel Foods. The approach taken by Health Canada in the safety assessment of GM foods is based upon scientific principles developed through expert international consultation over the last 20 years with agencies such as the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), and the Organization for Economic Co-operation and Development (OECD). The approach taken by Canada is currently applied by regulatory agencies around the world in countries such as the European Union, Australia/New Zealand, Japan, and the United States.
For additional news and commentary on this story, see:
https://geneticliteracyproject.org/2018/06/11/anti-gmo-groups-draw-fda-rebuke-over-misrepresentation-of-golden-rice-nutrition/
For those few who do not know Genetic Literacy Project’s corporate ties and agenda, here is important documentation from US Right to Know (USRTK) and also this from SourceWatch: (https://www.sourcewatch.org/index.php/Genetic_Literacy_Project) “The group regularly denies having any ties to Monsanto. However, in late 2017 documents were released as part of a lawsuit against Monsanto regarding the possible carcinogenicity of the pesticide glyphosate.[8] One document detailed Monsanto’s battle plan against the World Health Organization, which was planning to classify glyphosate as a possible carcinogen. On page five, Monsanto’s plan listed strategies and tactics for discrediting the World Health Organization before it released it’s ruling, and named several “industry partners” they would work with that included Biofortified AKA Biology Fortified, Inc., Sense About Science, Genetic Literacy Project, and Academics Review.”
That garbage article Ed Regis posted from the Genetic Illiteracy Project had a diliberately misleading statment at the very end of the article and it was purposeful. Here is the last statement:
“Carrots, spinach and sweet potatoes can’t be easily or cheaply grown in southeast Asia.”
Interestingly, Ed Regis knows this to be a misleading statement, because he himself posted this link showing that vegetables which were great sources of Vitamin A were native to Southeast Asia and grow very well. Nobody ever suggested Asia had to start growing Carrots, Spinach or Sweetpotatoes.
Here is Ed Regis link back on December 4, 2017 promoting the growing of native vegetables which will grow better in Asia for providing Vitamin A.
https://www.ncbi.nlm.nih.gov/pubmed/17413103
Before the biotech industry shills running the FDA cause more damage they need to be stopped! The
i nitiative to end vitamin A deficiency by giving these poor people a diverse source of vitamin A, this is
outright a better solution.
Such a lack considerations for the consequences of making a GMO rice, not tested in humans is wrong.
Rigorous testing with animals over generations is necessary. It’s a waste of public money. Farmers have no
Problems growing plenty of carrots at home to feed our friends and family.
i f there was data to support the safety and the nutrition of this Franken rice, where is it? Corporations will
s tart rearranging genes and they expect not to have issues with health?
Farming organically for high quality nutrient-dense produce is our solution, not chemicals intensive ag.
Reducing the need for global 1% elites to further control the food supply. We do not need this Franken rice. Its
ALL ABOUT CONTROL of the global trade of food. These corporations treat us like labrats in the process.
Utter environmental destruction with genetic pollution is unethical for contaminating an important crop.
Doubt can be a good thing in these cases and I wish these rich countries had some.
Special thanks to Dr. Latham and Dr. Wilson for this article and allowing me to update my comment.
Why would you deny the benefits of golden rice to the poor children going blind or even death?
The FDA actually says that it provides 60% of the vitamin A for a Bangladeshi child because they eat lots of rice!
You pertain to be intelligent people but you confirm that you don’t understand what’s written in the report.
Peter, I hope it is obvious that if it worked and if it was safety tested adequately and if we didn’t think it was a trojan horse for other GMOs and if it didnt cause various anti-competitive IP arrangements to be foisted on developing countries and if it didn’t suck resources from other better efforts then we would support it.
Jonathan Latham, two of those concerns aren’t your job. Rejecting a GMO because of the concern that, as with anything new, it will open the doors for more GMOs is asinine and unscientific, the term “trojan horse” you use is inappropriately value-laden. Likewise, “various anti-competitive IP arrangements” – not even sure what you mean by that, by all accounts Golden Rice deliberately not being patented doesn’t sound like a bad thing to me. It’s not your responsibility to worry about this, let another country’s politics take care of themselves.
Safety trials: it’s met the standards of several safety studies (https://www.irri.org/news-and-events/news/golden-rice-meets-food-safety-standards-three-global-leading-regulatory-0). How many more must it meet before we let people eat rice with the exact same vitamin in it that’s already found naturally in other plants?
As for whether the beta-carotene amount in the rice is high enough, given the amount consumed and consumption habits of the target demographic, to make a difference health-wise (bearing in mind that unmodified rice contains ZERO beta-carotene and that even a small, if still subpar amount in the staple diet, can still be clinically significant in preventing hypovitaminosis), that’s something that will simply have to be ascertained with pilot studies.
At any rate, it’s clear you have an agenda, and it’s disheartening.
I do not think you will find the term ‘trojan horse’ in the article. Re the amount, it will be very small. One wonders why invest so much into so little Vit A, when there are plenty of other solutions: https://www.independentsciencenews.org/health/vitamin-a-wars-the-downsides-of-donor-driven-aid/
What absolute nonsense!
ISN is grasping at low-bouyancy straws here. The FDA’s comments reflect the general sufficiency of proVitamin A in the diet of US consumers, as the supplementary letter from Marianna Naum at FDA articulates. For the layperson’s interpretation, if you get enough Vitamin A in your diet already, eating Golden Rice won’t make a difference. In a developing country where vitamin A is on average low-to-deficiency status, this could make a substantial difference. If your car is already driving at the speed limit, a better fuel won’t help, but if it is your limited by your engine complaining about crappy fuel which slows you down, a better octane will get you there faster. Duh!!
It is obvious except to those who wish to find minutae in the exceptions at the outer reaches of the distribution curve. This is such a manipulation of the clearly-stated intent of FDA (which must and are obliged to rely on carefully-worded science and not ideolgical, second-derivative misinterpretations).
It is shameful that you would try this on, frankly. You are all educated enough to report on this accurately.
Put your sound-science back on your heads, please.
With greatest respect,
Martin
Martin, I believe this has been addressed in earlier comments, in particular by nutritionist Marian Nestle’s blog, which is summarized and linked to in a comment above, and in which she details FDA’s requirements for nutrient content claims. The FDA determined “the concentration of β-carotene in GR2E rice is too low to warrant a nutrient content claim.” Also see my replies to Adrian Dubock in answer to the first comment.
If your concern is to ensure that Vitamin A deficiency is alleviated in malnourished populations, then I suggest you read the entire article, the comments and the materials referenced and linked to. To summarize, the published scientific data report: low and variable starting levels of beta-carotene in GR2E, its rapid degradation in storage, and further degradation with cooking, and a likely need for oil in the diet for its effective absorption. The combined data suggest that Golden Rice (GR2E) will make little if any positive contribution to vitamin A nutrition in targeted populations — malnourished adults and children.
Since the article was written, another paper has been published confirming the rapid degradation of β-carotene in Golden Rice during storage, and in different genetic backgrounds, and also that additional β-carotene degradation occurs during cooking:
Bollinedi, H., Dhakane-Lad, J., Krishnan, S. G., Bhowmick, P. K., Prabhu, K. V., Singh, N. K., & Singh, A. K. (2019). Kinetics of β-carotene degradation under different storage conditions in transgenic Golden Rice® lines. Food chemistry, 278, 773-779.
And a further complication is reported in a new paper:
Glover, D., Kim, S. K., & Stone, G. D. (2020). Golden Rice and technology adoption theory: A study of seed choice dynamics among rice growers in the Philippines. Technology in Society, 60, 101227. PDF of paper: http://pages.wustl.edu/files/pages/imce/stone/glover_et_al_2020_golden_rice_adoption.pdf
Glover et al. suggest that, as has routinely been the case with other GM crops, farmers are unlikely to grow GR2E unless subsidized to do so. This is because the genetic varieties used to breed GR2E for commercialization in the Philippines are not ones farmers would voluntarily choose to grow. If farmers won’t grow GR2E, no one can eat it. And if the government would have to subsidize GR2E, wouldn’t the money be better spent either ensuring malnourished people had access to adequate fruits and vegetables or, providing Vitamin A fortified vegetable oils, to ensure adequate nutrient levels and absorption?
I think it is a clear double standard for me.
FDA doesn’t allow golden rice due to pollination will effect other plants?
But These people are pushing golden rice to Philippine and Bangladesh.
These countries are rice eater countries. Pollination will effect closely to the livelihood of these people. Fixing Vitamin A can be done with other veggie why they need to stretch it to GMO rice that not even FDA approved to cultivate in its own country?
Please think again of the logic