A GMO Corn and Its Non-GMO Parent Are Not Substantially Equivalent (Page 2)

Michelle Perro, MD
Published: February 12, 2018
Results from animal testing show differences between rats fed GMO versus non-GMO corn. Photo: Understanding Animal Research.
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Related studies
In an effort to gain a deeper insight into the findings of kidney and liver pathology in rats fed NK603 corn over a two-year period (Séralini et al, 2014), a full transcriptomics and metabolomics analysis was conducted of the kidneys and livers from the female animals (Mesnage et al, 2017a). Transcriptomics analysis looks at the gene expression patterns in the organs and metabolomics analysis looks at the metabolites present in the organs.
Tissues from the liver and kidneys of three groups of rats were tested:

  • Rats fed a diet consisting of 33% GMO NK603 corn that had been sprayed once with Roundup herbicide during cultivation
  • Rats fed a diet of 33% GMO NK603 corn that was not sprayed with Roundup during cultivation
  • Rats fed a control diet of 33% non-GMO corn that was the nearest available relative to the GM corn, but without the genetic modification (called the non-GMO isogenic variety).

Statistically significant changes were observed in the levels of some metabolites in test groups compared to controls; 23 in NK603 + Roundup kidneys, 51 in NK603 kidneys, 12 in NK603 + Roundup livers and 56 in NK603 livers. Several metabolites that were indicative of organ damage were found to be altered in test animals fed the GMO corn as compared with control animals fed the non-GMO isogenic corn. For example:

  • The metabolite 3-methylhistidine was found to be elevated in the kidney tissue of animals fed GMO NK603 corn, both with and without Roundup application. This is an indicator of protein catabolism (breakdown), in particular from the degradation of muscle tissue. The degradation of muscle tissues generates free 3-methylhistidine, which is slowly released into the bloodstream, from where it is filtered by the kidneys. The measurement of 3-methylhistidine provides an index of the rate of muscle protein breakdown.
  • In the liver of animals fed GMO NK603 corn, both with and without Roundup application, there was an accumulation of potentially toxic polyamines (putrescine and spermidine), which could suggest an elevated metabolic state. This state of increased metabolic activity can signal underlying health issues and/or injury to this organ. Typically, polyamines are highly active in rapidly proliferating cells, although their levels fluctuate during the cell cycle and accumulate in the regenerating liver. This suggests that the liver may have been damaged and is trying to repair itself. However, the increased levels of polyamines in the liver could also be explained by an increased dietary intake since the NK603 corn tested in this study had previously been found to contain more polyamines than its non-GMO near-isogenic counterpart (Mesnage et al, 2017a).

Statistical analysis
In spite of the above findings, when the dataset as a whole was statistically analyzed by applying a tool called the Benjamini-Hochberg correction, a high score was obtained, implying that the changes in individual metabolites could have arisen by chance (Mesnage et al, 2017a). However, it is important to note that this does not mean that the significant changes seen were not real or valid. It simply means that definitive conclusions cannot be drawn from these findings.
In addition, differences observed between individuals within a given group were greater than the metabolic effect of the different diets (Mesnage et al, 2017a).
Due to these factors, the authors of the study concluded that the biological relevance of the statistically significant differences presented in this study was unclear and that it was not possible to draw firm conclusions of harm or safety regarding the effects of consumption of this GMO corn (Mesnage et al, 2017a).
The statistical analysis suggests that the way to resolve the uncertainties regarding any toxic effects arising from consumption of GMO NK603 corn is to perform an experiment with larger numbers of animals. This would increase the statistical power of the study such that even low-level toxic effects, as may have been seen here, are highlighted.
In contrast, clear results were obtained from a similar molecular profiling analysis (Mesnage et al, 2017b) of the liver tissues of rats from the same original long-term feeding study (Séralini et al, 2014) that had been given a very low dose of Roundup in their drinking water, below regulatory permitted levels. In the molecular profiling analysis, a protein composition profile (“proteomics”) and small molecule metabolite biochemical profile (“metabolomics”) investigation of the same liver samples showed that the Roundup-fed rats suffered from non-alcoholic fatty liver disease (NAFLD). The study is unique in that it is the first to show a causative link between consumption of Roundup at a real-world environmental dose and a serious disease condition (Mesnage et al, 2017b).
EU research study
After the publication of the initial animal feeding study in which rats were fed NK603 maize and very low doses of Roundup over a long-term two-year period (Séralini et al, 2014), the EU launched a two-year carcinogenicity study with GMO NK603 corn (G-TwYST, 2014).] The research project is called G-TwYST and the results are expected to be announced in 2018.
However, the Germany-based research group Testbiotech has raised questions about the scientific integrity and independence from industry of G-TwYST and its interconnected project, GRACE (Testbiotech, 2015). In 2013 a report published by Testbiotech showed that several members of the GRACE and G-TwYST research teams had strong ties with institutions that are financed by industry, either completely or to a large extent. Amongst those institutions were the International Life Sciences Institute (ILSI) and International Society for Biosafety Research (ISBR) (Bauer-Panskus and Then, 2013).
As evidence that the industry ties of the researchers might influence their presentation and interpretation of scientific results, Testbiotech pointed to (Testbiotech, 2015) a publication by the GRACE team of the results from a feeding study on rats fed a GMO Bt corn, MON810, over 90 days (Zeljenková et al, 2014). (GMO Bt crops are engineered to express Bt toxins, which are insecticides derived from a soil bacterium.) The GMO corn-fed rats had decreased total serum protein and pancreas weight, with the latter accompanied by increased blood glucose levels. These effects were statistically significant and dose-dependent, reinforcing the strength of the findings. Nevertheless, the authors dismissed them, among other effects of the GMO diet, as toxicologically irrelevant (Zeljenková et al, 2014). It is important that the G-TwYST research team avoid such practices in reporting the NK603 results.

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Action Items

Regulatory Oversight

 Enhanced Regulations:

  • The FDA and other regulatory bodies must establish stricter guidelines and permissible limits for toxic metals in infant formula. This action has been already put into our place since our meeting with the FDA prior to the release of our data reported in this blog by Moms Across America.

Regular Testing:

  • Mandatory, routine testing for heavy metals in all infant formula products should be enforced to ensure compliance with safety standards.

Transparent Reporting:

  • Companies should be required to disclose test results publicly, promoting transparency and accountability.

Proactive Measures by Companies

Sourcing and Production Controls:

  • Infant formula manufacturers must implement rigorous controls over their raw materials and production processes to minimize contamination.

Regular Audits:

  • Frequent internal and third-party audits should be conducted to ensure adherence to safety protocols and identify potential sources of contamination.

Research and Development:

  • Investment in research to develop technologies and methods for removing or reducing heavy metal content in infant formulas.

Remediation Solutions

Advanced Filtration Systems:

  • Implementing advanced filtration technologies during production to remove toxic metals.

Ingredient Substitution:

  • Identifying and using alternative, less contaminated sources of raw materials.

Chelating Agents:

  • Exploring the use of safe chelating agents that can bind to metals, making them less bioavailable and reducing their toxic effects.

What the Data Means to Moms

For mothers and caregivers, these findings can be alarming. However, it is essential to understand the implications and take informed steps to ensure the safety of their infants. Breastfeeding remains the best option for infant nutrition, when possible, as it naturally minimizes exposure to contaminants.

Recommendations Based on Data

Prioritize Breastfeeding:

  • Whenever possible, opt for breastfeeding to provide the safest and most natural nutrition for your baby.

Choose Carefully:

  • When breastfeeding is not an option, select infant formulas that have been independently tested and verified for low levels of toxic metals.
  • Maximize moms’ diet utilizing organic regenerative whole foods, including an array of fermented foods, filtered water, and nutritional supplements, such as prenatal vitamins and probiotics.

Stay Informed:

  • Keep abreast of the latest research and reports on infant formula safety to make informed decisions.

Advocate for Change:

  • Support initiatives and petitions calling for stricter regulations and safer infant formula products. (See the end of this article for a petition/call-to-action.)

Sample Considerations

The recommendations based on our findings proved challenging since all formulas tested positive for aluminum and lead. Other difficult considerations were based on the fact that not all metals are equally toxic and it is unclear whether having more metals at lower amounts was more toxic than fewer metals with higher amounts. The literature did not prove helpful in this regard.

Hence, the best attempts were made to offer advice for concerned parents based on this one study of toxic metals without other concomitant toxicants studied. A scorecard was designed, rating the formulas from 1 – 3, with 1 being the best based on 5 toxic metals studied and without consideration of other factors. The formulas were chosen for lowest levels of lead, mercury and cadmium. Lower levels of aluminum were considered since they all tested positive. There were no ideal formulations, and the recommendations were based on the 20 tested. There were differences in the two samples of the same formula which may not be statistically significant.

Overall formula recommendations:1

  1. Similac Sensitive infant formula
  2. Kirkland ProCare Non-GMO infant formula – NOTE: My top choice factoring in other contaminants/pesticides
  3. PurAmino hypoallergenic powder infant formula (For babies with digestive issues requiring predigested formulas)

Formula recommendations:2

  1. Gerber Good Start Gentle Pro
  2. Earth’s Best Organic Sensitivity Formula

Formula recommendations:3

  1. Enfamil Sensitive Infant Formula
  2. Similac Total Comfort Infant Formula
  3. Up & Up Gentle Premium Powder Infant Formula
  4. Up & Up Non-GMO Hypoallergenic Powder Infant Formula
  5. Enfamil Plant-Based Soy Powder Infant Formula

Strategic Recommendations

Targeted Research

Understand Contamination Sources:

  • Conduct further research to understand the sources of metal contamination in infant formulas, including soil contamination with pesticides, water used in manufacturing, and packaging materials.

Long-Term Health Impacts:

  • Investigate the long-term health impacts of chronic exposure to low levels of these metals in infants.

Consumer Guidance

Interpreting Lab Results:

  • Educate parents on how to interpret lab results and select formulas with the lowest possible contamination levels.

Support Safe Feeding Practices:

  • Provide resources and support for parents to transition to safer feeding practices, whether through breastfeeding support or safer formula alternatives.

Enhanced Testing Protocols

Rigorous Testing:

  • Mandate formula manufacturers to adopt more rigorous testing protocols, including testing for a broader range of contaminants and more frequent testing intervals.

Standardized Procedures:

  • Advocate for standardized testing procedures across the industry to ensure consistency and reliability in reported results.

Supply Chain Transparency

Transparency:

  • Push for greater transparency in the supply chain of infant formula ingredients.
  • This includes sourcing, production processes, and quality control measures.

Traceability:

  • Implement traceability measures to identify and mitigate contamination sources promptly.

Policy and Advocacy

Environmental Contamination:

  • Support policy initiatives aimed at reducing environmental contamination, as many of these metals enter the food chain through polluted air, water, and soil.

International Cooperation:

  • Advocate for international cooperation to address the global nature of food safety, as ingredients are often sourced from multiple countries.

Summary

The presence of toxic metals in infant formula is a critical issue that demands immediate action.

Public education is crucial to raise awareness among parents and caregivers about the potential risks and safety measures. Regulatory action by Congress is necessary to empower the FDA and other agencies to enforce stringent safety standards. Additionally, formula companies must take corrective actions to ensure their products are safe.

To address this issue, we are initiating a petition to urge Congress to remove any barriers preventing the FDA from enforcing these necessary regulations. In the meantime, parents can consider various supplements that may help offset the toxicity, although this should be done in consultation with healthcare professionals.

By working together—regulators, companies, and consumers—we can ensure that infant formula products are safe and healthy for our most vulnerable population, our babies.

Our Petition:

Please cut and paste this letter, add 1-3 sentences at the top to personalize it and increase the chances of it being read, and send it directly to your Senator and Representative today!

Find your Senator and Representatives’ emails and telephone numbers here.

Dear Senator_____ or Representative _______,

I am writing to ask for your support in making baby food and formula safer for our babies. Will you support the Baby Food Safety Act of 2024 and insist that baby formula is included? Please authorize the FDA with the ability to do their job and protect human health. Baby formula is often the ONLY food a baby consumes for the first six months of their lives and must be monitored for heavy metals. Our babies ARE our future and they are the most vulnerable. If swift action is not taken, babies from both sides of the aisle will continue to be severely impacted and their mental, physical, and reproductive health issues will affect the future of America.

GMOScience and The New MDS, Moms Across America, a national educational nonprofit dedicated to empowering mothers and others to create healthy families and communities, today announces the results of testing for five toxic metals in 20 infant formula products. Samples included organic as well as non-organic and plant-based as well as animal product formulas sold by four of the major producers of infant formula in the United States and across the globe. Two samples of each product were tested, for a total of 40 samples.

Concerning findings include:

  • 100% of the 40 samples tested contained aluminum and lead.
  • 57% of the samples tested positive for arsenic, 55% for mercury, and 35% for cadmium.
  • Six of the 20 formulas were positive for all five toxic metals in both samples.
  • At 41,000 ppb, aluminum levels in a goat’s milk baby formula were 4000 – 40,000x higher than other metals in the formulas tested and exceed limits set by the FDA for maximum safety level of aluminum for a preemie.
  • Levels of mercury in four samples measured above the limit allowed by the FDA in drinking water.
  • Levels of cadmium in both samples of one formula were nearly twice the level allowed in drinking water.

The FDA concluded many years ago that babies and young children are particularly vulnerable to the harmful effects of food contaminants because of their small bodies and rapid cellular growth. In 1962, the FDA launched the Total Diet Study, recently published in July, 2002, analyzing 910 foods, including only four infant formulas. Two of the four formulas contained toxic metals, including uranium. In April 2021, the FDA announced its “Closer to Zero” plan, wherein it committed to proposing allowable levels of lead in various baby foods by April 2022, levels of inorganic arsenic by April 2024, and cadmium and mercury sometime after 2024. None of those deadlines, however, have been met, and all of them have been removed from the Closer to Zero website.

To date, the only actionable limits the agency has set are for one toxic metal only (inorganic arsenic) in one type of baby food product (infant rice cereal).

Citing findings of nearly 400 childhood lead poisoning cases in fall 2023 linked to recalled cinnamon applesauce pouches. A coalition of 20 Attorneys General led by New York’s Attorney General Letitia James issued a letter to the FDA on February 15 of this year to call on the federal agency to protect babies and young children in the United States from lead and other toxic metals in baby food. That letter followed an October 2021 petition and subsequent June 2022 petition, asking the FDA to issue specific guidance to the baby food industry to require testing of all finished food products for lead and other toxic metals.

It has been over two years! Action must be taken now!

Moms Across America, GlyphosateFacts, and GMOScience presented the new baby formula test results and science from Stephanie Seneff and others in meetings with congressional representatives and the FDA in Washington, DC from April 29 to May 2. They were informed by Jim Jones, Deputy Commissioner for Human Foods at the FDA, that the agency is waiting for Congress to pass legislation that would mandate testing for lead and other harmful chemicals in food. On May 9, US lawmakers introduced the Baby Food Safety Act of 2024, which, with Congressional approval, would allow the FDA to regulate and enforce limits on levels of heavy metals found in baby food and potentially formula.

Please support the Baby Food Safety Act of 2024 and insist that baby formula is added to the bill so that the FDA may regulate and monitor levels of heavy metals in both baby food and baby formula.

Thank you.

Signed with Gratitude,

Your constituent __________________

References:

  1. https://www.fda.gov/food/resources-you-food/infant-formula#oversee
  2. https://www.fda.gov/food/resources-you-food/infant-formula
  3. https://www.fda.gov/food/buy-store-serve-safe-food/handling-infant-formula-safely-what-you-need-know
  4. https://www.fda.gov/food/consumers/agricultural-biotechnology
  5. https://www.fda.gov/food/people-risk-foodborne-illness/food-safety-infants-toddlers
  6. https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information/enforcement-discretion-manufacturers-increase-infant-formula-supplies#regular
  7. https://www.fda.gov/media/71695/download?attachment
  8. https://www.scirp.org/journal/paperinformation?paperid=53106
  9. https://www.researchgate.net/profile/David-Kennedy-40/publication/333582853_Environmental_toxicants_and_infant_mortality_in_America_Peertechz_Journal_of_Biological_Research_and_Development_11_36-61/links/5d111f6592851cf440492ee1/Environmental-toxicants-and-infant-mortality-in-America-Peertechz-Journal-of-Biological-Research-and-Development-11-36-61.pdf
  10. unsafe at any level
  11. https://reneedufault.com/
  12. https://gmoscience.org/
  13. https://www.momsacrossamerica.com/
  14. https://www.ewg.org/research/ewgs-guide-infant-formula-and-baby-bottles
  15. https://www.inonaround.org/baby-formula/
  16. https://projecttendr.thearc.org/
  17. https://hbbf.org/
  18. https://www.hbbf.org/solutions/healthy-baby-foods
  19. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4415012/: Developmental pesticide exposure reproduces features of attention deficit hyperactivity disorder
  20. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8871549/:Prenatal Mercury Exposure and Neurodevelopment up to the Age of 5 Years: A Systematic Review
  21. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5461492/:Fetal and postnatal metal dysregulation in autism
  22. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1764574/:Lead and mercury exposures: interpretation and action

https://www.nass.usda.gov/Surveys/Guide_to_NASS_Surveys/Chemical_Use/WheatPostharvestChemicalUseFactSheet.pdf

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