Prof. Joe Cummins and Dr. Mae-Wan Ho rebut USDA conclusion that transgenic DNA and RNA are non-toxic
The United States Department of Agriculture Animal and Plant Health Inspection Service (USDA/APHIS) has recently granted non-regulatory status to a transgenic plum resistant to plum poxvirus [1] after receiving 1 725 comments from state farm bureaus, organic growers, growers associations, consumer groups, agriculture support industries, academic professionals and individuals, with respondents against the petition (1 708) outnumbering those in favour (17) by a factor of 100 to 1.
APHIS was clearly biased in favour of the petition in their Environmental Assessment, and attempted to justify its decision by stating: “The majority of academic researchers, as well as the state farm bureaus that submitted comments, support granting non-regulated status to the C5 plum. The majority of those who submitted comments opposing granting non-regulated status were submitted by organic grower or consumer groups, organic growers, those who favour organic agriculture or those who are opposed to genetic engineering technology in general.”
APHIS maintains that, in general RNA and DNA have no toxic properties [1] based primarily on a Food and Drug Administration (FDA) 1992 GRAS notice on transgenic microbes used to produce animal proteins under contained conditions, which is irrelevant and highly misleading when applied to environmental release in the case of the C5 transgenic plum. More importantly, the FDA notice is obsolete in view of numerous scientific findings made since, and its recommendations should be rejected forthwith. For example, the extensive regulatory role of small RNA molecules, similar to those in the virus resistance of C5 plums, was not mentioned in the FDA notice, as it had not yet been discovered; nor indeed, the potentially fatal effects of such RNA molecules in mammals highlighted in our detailed comment to the USDA [2] (USDA Proposes to Deregulate Its Own Transgenic Plum, SiS 31).
Despite the fact that a small RNA molecule was present in high concentrations in the transgenic plum, APHIS maintains that: “Nucleic acids (i.e., RNA and DNA) are present in all living organisms and are not known to have any toxic properties. Nucleic acids are considered to be “generally recognized as safe” (GRAS) by the U.S. Food and Drug Administration (FDA) (FDA 1992) and exempt from the requirement of a tolerance under the Federal Food Drug and Cosmetic Act by the U.S. Environmental.”
APHIS dismissed comments questioning the safety of the small RNAs responsible for providing resistance in C5 plum, including one comment from us [2] pointing to the use of small RNAs in RNA interference (RNAi) gene therapy and its potential adverse health effects. APHIS insists that, “the safety of nucleic acids is widely accepted”, as both RNA and DNA are part of all food products that we consume; further, “given that plant viruses infect a tremendous amount of the fruits and vegetables that we consume, it is highly likely that humans have been exposed to the same or similar viral RNA that may be expressed in a coat-protein expressing plant.” As to the concern about safety arising from findings in RNAi gene therapy, APHIS states that such RNAs “would be specifically designed and intended for targeted use in humans, and they would be significantly different than those found in the C5 plum.”
All of the APHIS statements cited are false and or misleading, and are contradicted by extensive scientific literature.
It is questionable whether people tend to eat virus-infected fruits and vegetables; also, potentially toxic small RNA molecules are produced, not by the virus but by the transgenic plum as the result of the insertion of viral DNA into the plum genome. Virus infected non-transgenic plums would not make large quantities of the small RNA that prevents virus replication.
There is substantial evidence that the small RNA molecules may be toxic to animal cells (see below), and produce off target effects in plants. Contrary to the statement made by APHIS (above) suggesting that specific sequences were designed for gene therapy, the researchers tested many different RNA sequences for toxicity to mice. Out of 49 sequences tested, the majority (36) were severely toxic, 23 were lethal in every case, killing the animals within two months [3] (Gene Therapy Nightmare for Mice, SiS 31). The fact is, the small RNA molecules produced in the transgenic plum have never been tested for their toxicity in animals and they have not previously been produced in quantities in non-transgenic plums or any other crop plants. The potential toxicity of small RNAs is featured in a number of publications between 2004 and 2006 [4-9], which show that APHIS’ conclusion that RNA molecules are safe for humans is false and invalid.
APHIS further maintains that DNA molecules are intrinsically non-toxic based on the 1992 FDA GRAS notice [1]. Even though toxic DNA is not a major issue in the transgenic plum, it is worth pointing out that the toxicity of certain DNA molecules is well established [10-12]. DNA molecules are recognized by the immune system as a means of activating defence against pathogenic bacteria and viruses. A strong immune reaction is triggered; even one leading to death in mammals, as stated in a report published in 2004 [13]:
“The mammalian innate immune system has the ability to recognise and direct a response against incoming foreign DNA. The primary signal that triggers this response is unmethylated CpG motifs present in the DNA sequence of various disease-causing pathogens. These motifs are rare in vertebrate DNA, but abundant in bacterial and some viral DNAs. Because gene therapy generally involves the delivery of DNA from either plasmids of bacterial origin or recombinant viruses, an acute inflammatory response of variable severity inevitably results. The response is most serious for non-viral gene delivery vectors composed of cationic lipid-DNA complexes, producing adverse effects at lower doses and lethality at higher doses of complex.”
APHIS’ conclusion on the lack of toxicity of DNA is evidently also false and misleading.
We have stated on many occasions (most recently in GM Food Nightmare Unfolding in the Regulatory Sham [14], I-SIS scientific publication) that transgenic DNAs, as opposed to non-transgenic DNA, share certain features that make them potentially unsafe.
In conclusion, APHIS has falsely claimed that RNA and DNA molecules are intrinsically safe for humans, based solely on an obsolete FDA notice now refuted by numerous observations.
This is the latest in a long string of false and invalid claims on safety from the USDA. I-SIS has submitted at least 34 detailed objections containing safety warnings against deregulation or field releases of genetically modified organisms (GMOs) to the USDA and other US regulatory agencies since 2001 [15], all to no avail. The same goes for ISIS’ submissions to the European Food Safety Authority and the UK Food Safety Authority [14].
However, the US judiciary system appears to be catching up with USDA’s cavalier attitude towards environmental safety assessment [16] (Approval of GM Crops Illegal, US Federal Courts Rule , SiS 34), and has imposed the first ban on a GM crop (alfalfa) in the country. The US has joined the avalanche of bans and moratoriums hitting GM crops around the world over the past year as policy makers are waking up to the irrefutable mass of evidence piling up on the hazards inherent to GMOs [14, 17, 18] (No to GMOs, No to GM Science, SiS 35; GM Science Exposed: Hazards Ignored, Fraud, Regulatory Sham, and Violation of Farmers' Rights. ISIS CD book).