"But there is a 'creation myth' that is blind to both, nature's creativity and biodiversity as well as to women's creativity, intelligence and knowledge. According to this 'creation myth' of capitalist patriarchy, rich and powerful men are the 'creators.' They can own life through patents and intellectual property. They can tinker with nature's complex evolution over milennia and claim their trivial yet destructive acts of gene manipulation as 'creating,' life, food and nutrition." --Vandana Shiva, at Common Dreams, "Tackling Monocultures of the Mind"
https://www.commondreams.org/views/2013/04/24/tackling-monoculture-mind
Manipulating genes, the tinkering of life at the molecular level, is based on a level of arrogance. A shotgun approach to fixing biological problems. Blasting through cellular matter, grabbing a gene of interest, and replacing it with another gene: is coupled with the belief that such manipulation has only one specific consequence. The web of life, its complexity is discounted. We have a brand new Human Milk Oligosaccharide (HMO) industry, which is part of the infant formula industry.
https://www.prnewswire.com/news-releases/human-milk-oligosaccharides-market-worth-usd-170-4-million-by-2024-hexa-research-832644513.html
It has found a way to harness a specific bacteria (e.coli in most cases) to create a Human Milk Oligosaccharide. And companies have the audacity to tell the US FDA that this manipulated product is identical to the real HMOs found in human breast milk. It's safety is assured based on the safety of breastfeeding. And the US FDA had no questions regarding these statements.
Glycom's FDA GRAS #650 statement on the history of safe consumption regarding their 2'-FL oligosaccharide for use in baby formulas/food, etc. This particular 2'-FL is manufactured by fermentation with E. coli K-12 SCR6 genetically engineered by 7 modifications and using antibiotic resistance genes ampR (ampicillin) and tetR (tetracycline).
"2'-FL is one of the naturally occurring fucosylated milk oligosaccharides present in some mammalian milks (Urashima et al., 2002; Castanys-Muñoz et al., 2013), with markedly highest concentrations of 2'-FL occurring in milk from lactating women (Kuhn et al., 1955). 2'-FL therefore has an established history of safe consumption by infants consuming human milk." (page 32)
https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm513832.pdf
On page 34 of the FDA GRAS #650 pdf document under toxicological studies, they state that safety is based on published studies showing, "the corresponding history of safe consumption of 2'-FL by breast feeding infants."
Safety is based on the breastfeeding infant? One of Glycom's patents, patent #9902984, entitled "Fermentative production of oligosaccharides."
"In this invention, the term "genetically modified cell" preferably means
a cell in which at least one DNA sequence has been added to, deleted
from or changed in its genome, so that the has a changed phenotype.
This change in phenotype alters
the characteristics of the genetically modified cell from that of the
wild type cell. Thus, the genetically modified cell can perform at
least an additional chemical transformation, when cultured or fermented,
due to the added or changed DNA that
encodes the expression of at least one enzyme not found in the wild type
cell, or the genetically modified cell cannot perform a chemical
transformation due to the deleted, added or changed DNA that encodes the
expression of an enzyme found in the wild
type cell. The genetically modified cell can be produced by well-known,
conventional genetic engineering techniques. The genetically modified
cell can be bacteria or a yeast but preferably is a bacterium.
Preferred bacteria include Escherichia coli,
Bacillus spp. (e.g. Bacillus subtilis), Campylobacter pylori,
Helicobacter pylori, Agrobacterium tumefaciens, Staphylococcus aureus,
Thermophilus aquaticus, Azorhizobium caulinodans, Rhizobium
leguminosarum, Neisseria gonorrhoeae, Neisseria meningitis,
Lactobacillus spp., Lactococcus spp., Enterococcus spp., Bifidobacterium
spp., Sporolactobacillus spp., Micromomospora spp., Micrococcus spp.,
Rhodococcus spp., Pseudomonas, particularly E. coli."
Where is the public outcry over an industry using the safety of breastfeeding to declare that a product that made in a laboratory using e.coli is identical to the component made in a woman's breast? Is the public even aware of what this new industry claims to government officials? Genetic engineering? What is that? In our food? No can't be. And genetic engineering in baby formula? No can't be.
As I understand the research, the number of Human Milk Oligosaccharides (HMOs, the real component not the manufactured) is guessed at from as low as 100-500 different HMOs. No two lactating women have identical HMOs, and each woman has HMOs that vary over time. For example, about 70% of women have the 2'-FL HMO. This component seems dependent upon a woman's blood type. Thus providing all formula fed infants with 2'-FL seems to be irrational without understanding the possible ramifications that might occur to infants who, if breastfed would never ingest this component. Lars Bode's research paper, "Human milk oligosaccharides: Every baby needs a sugar mama."
https://academic.oup.com/glycob/article/22/9/1147/1988076
Human milk is not only species specific, it is individually specific. Thus duplication is impossible on a basic level, because no manufacturer will have time, the money, the resources to duplicate that individuality. Mass production of food means that there are major losses in nutrients. And this is not the only issue. In order to preserve shelf life in manufactured foods, additives are used so that the can or plastic tubs/bottles of infant formula can sit on the store shelf for 24-36 months. It is a lifeless product unlike human milk that is alive. The ability to duplicate human milk components by genetic engineering or any other method is a myth.
What about clinical trials of infant formula with HMOs, showing the safety of these novel ingredients? The research paper in Nutrients in September of 2018 entitled, "Human Milk Oligosaccharides: 2'-Fucosyllactose (2-FL) and Lacto-N-Neotetraose (LNnT) in Infant Formula," states:
"Today, the amount of data available on HMO supplementation in infant
formula from clinical trials in infants is still limited. More data are
definitely needed. According to the data from the few studies,
differences in clinical outcome of supplemented vs. non-supplemented
formula are not yet conclusive [72,73,74,75,76].
The different primary outcomes of the different trials contribute to a
lack of coherent results. The cost-benefit ratio also needs further
evaluation. In addition, the optimal concentration of HMO added needs
further adjustment. And of course, there is the fact that only one or
two HMOs are added to infant formula, while mother’s milk contains 200
different oligosaccharides. Supplementation with more HMOs could result
in further evidence of benefit."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6164445/
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