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Docket No. APHIS–2012–0025
Regulatory Analysis and Development, PPD
APHIS, Station 3A–03.8
4700 River Road Unit 118
Riverdale, MD 20737–1238

December 9, 2013

The Cornucopia Institute is a 501(c)(3) public interest farm and food policy research organization.  We are proud to represent approximately 9,000 members, who support healthy food and sustainable farms.  We submit the following comments on Docket # APHIS-2012-0025 to express our opposition to the approval of the first genetically engineered apples – the Arctic Golden Delicious and Arctic Granny Smiths.

Cornucopia opposes the release of any genetically engineered (GE) apple varieties.  We disagree with the USDA’s assumptions of safety regarding the ArcticTM Apple Events GD743 and GS784.  Specifically, we note that “safety” of GE apples has not been established, it is based on assumptions and out-dated research.

In the following comments, we present sections of the draft Environmental Assessment (EA) and the Plant Pest Risk Assessment (PPRA), followed by our rebuttal of the conclusions.

The PPRA explains that “ArcticTM apple events GD743 (‘Golden Delicious’) and GS784 (‘Granny Smith’) were produced by Agrobacterium tumefaciens-mediated transformation.”  The process includes insertion of nptII, neomycin phosphotransferase type II gene from E. coli Tn5. This gene allows transformed apple tissue to grow on a medium containing the antibiotic kanamycin, but confers no benefit to the apple plant.

In other words, every cell of every GE apple tree, including the apple fruit, and the roots of the trees, will show resistance to kanamycin.  The transfer of GE DNA from plants to bacteria is a real possibility.  Page 11 of the PPRA states:  “NPTII is a common protein found in genetically engineered plants that have been widely planted across the U.S. and in other countries. No issues related to health or environmental safety have been noted to date.”  We believe that there are real safety issues associated with the transfer of kanamycin resistance from GE apples to bacteria.

As humans eat the GE apples, they ingest GE DNA containing the gene for kanamycin resistance.  This gene can be transferred to the bacteria that inhabit the human digestive system.  This transfer has been demonstrated with GE soy.  After volunteers ate just one meal of GE soy, bacteria in their digestive systems contained the DNA from the GE soy foods.[1]  If humans eat GE apples, there is a real possibility that bacteria in the human digestive systems could develop kanamycin resistance.  This would be a major public health threat.  Resistance to antibiotics is a major concern among medical professionals, and kanamycin is commonly used in human medicine.

Regarding horizontal gene transfer (HGT) the PPRA states:  “FDA has evaluated HGT related to the use of antibiotic resistance marker genes, and concluded that the likelihood of transfer of antibiotic resistance genes from plant genomes to microorganisms in the gastrointestinal tract of humans or animals, or in the environment, is remote (FDA, 1998).”  This conclusion from 1998 is no longer valid.  Numerous recent studies have demonstrated that HGT does indeed occur.  The DNA from GE crops has been transferred directly into animals.  When livestock were fed GE crops, the GE DNA was taken up by the animal’s organs and detected in the meat, milk, and fish that people eat.  [2][3][4][5][6]  When conducting a PPRA, it is essential to consult the most recent scientific literature, rather than basing conclusions on 15-year-old studies.

GE DNA can also spread to bacteria on the plant and in the soil.  The GE DNA, along with the antibiotic resistance, can spread to phyllosphere bacteria.  Orchardists would find that disease control was much more difficult if the kanamycin resistance gene were to spread to Erwinia amylovora bacteria common on apple trees.  This bacterium causes fireblight, a serious disease of apple trees, which is controlled by using antibiotics.  Transfer of kanamycin resistance to fireblight bacteria could make it more difficult to control this disease, as well as other bacterial diseases of apples.

In the soil environment, the GE DNA can persist in the soil for at least a year,[7] where it can be taken up by natural soil bacteria and be incorporated into their genomes.[8]  This spread would not be detected in the initial field tests of GE crops, because it is rare, and scientists were not specifically looking at this type of environmental contamination.  As GE crops become widespread and are planted repeatedly for many years, the likelihood increases that GE DNA will spread to soil bacteria.  In apple orchards, GE DNA from the trees will repeatedly be added to the orchard soil as leaves fall from trees each autumn.

Page 11 of the PPRA states:  “Based on the nutritional composition data and lack of toxicity and allergenicity of nptII gene products, APHIS concludes that consumption of GD743 and GS784 plant or plant products by mammals and other nontarget organisms is unlikely to cause any adverse impact on their survival and reproduction.”

Based on results from recent scientific studies, we believe that consumption of GE apples will cause harm to humans and animals that consume the fruit.  In order to determine adverse impacts of eating GE foods, it is necessary to conduct long-term feeding studies.  The above conclusion is unsubstantiated, due to lack of research.  Certainly feeding studies must be conducted by independent scientists before feeding these GE apples to humans.  There is no proof that these GE apples are harmless, but there is evidence to suggest that they are harmful to humans and wild animals, such as the deer and coyotes that commonly feed on fallen apples.  Independent scientists who have conducted feeding studies over a two-year period, the typical lifespan of lab rats, have raised serious concerns about the health effects of GE crops.  Scientists reported harm to the liver, kidneys, digestive and immune systems, as well as other health problems.[9][10]

The conclusion of “safety” in the PPRA and EA was drawn without the needed scientific research and is in direct conflict with recent scientific findings.  Scientists worldwide have expressed concerns about the safety of GE crops, and have indicated a need for additional research.

In October of 2013, more than 230 scientists signed the following statement: “we strongly reject claims … that there is a “scientific consensus” on GMO safety. …  We feel compelled to issue this statement because the claimed consensus on GMO safety does not exist.”  The statement was issued by ENSSER, the European Network of Scientists for Social and Environmental Responsibility.

We urge you not to approve the genetically engineered ArcticTM Apple.

Pamela Coleman, Ph. D.
Farm and Food Policy Analyst
The Cornucopia Institute


Additional references:

  1. Antoniou, M., Robinson, C., and Fagan, J.  2012.  GMO Myths and Truths: An evidence-based examination of the claims made for the safety and efficacy of genetically modified crops.  Earth Open Source.
  2. USDA-APHIS. 2013. “Draft Plant Pest Risk Assessment for Okanagan Specialty Fruits Inc.’s Non-browning Apple Events GD743 and GS784.”


[1] Netherwood T, et al. 2004.  Assessing the survival of transgenic plant DNA in the human gastrointestinal tract. Nat Biotechnol. 22(2): 204–209.

[2] Tudisco R, et al. 2010.  Fate of transgenic DNA and evaluation of metabolic effects in goats fed genetically modified soybean and in their offsprings. Animal. 4: 1662–1671.

[3] Ran T, et al. 2009.  Detection of transgenic DNA in tilapias (Oreochromis niloticus, GIFT strain) fed genetically modified soybeans (Roundup Ready). Aquaculture Research. 40: 1350–1357.

[4] Chainark P, et al. 2008.  Availability of genetically modified feed ingredient: investigations of ingested foreign DNA in rainbow trout Oncorhynchus mykiss. Fisheries Science. 74: 380–390.

[5] Sharma R, et al. 2006.  Detection of transgenic and endogenous plant DNA in digesta and tissues of GMO sheep and pigs fed Roundup Ready canola meal. J Agric Food Chem. 54(5): 1699–1709.

[6]Mazza R, et al. 2005. Assessing the transfer of genetically modified DNA from feed to animal tissues. Transgenic Res. 14(5): 775–784.

[7] Lerat S, et al. 2007.  Quantification and persistence of recombinant DNA of Roundup Ready corn and soybean in rotation. J Agric Food Chem. 55(25): 10226-10231.

[8] Pontiroli A,et al. 2007.  Fate of transgenic plant DNA in the environment. Environ Biosafety Res. 6(1-2): 15-35.

[9] Dona A, and Arvanitoyannis IS. 2009.  Health risks of genetically modified foods. Crit Rev Food Sci Nutr. 49(2): 164–175.

[10] Antoniou, M, et al.  2012.  GMO Myths and Truths: An evidence-based examination of the claims made for the safety and efficacy of genetically modified crops.  Earth Open Source, page 42.

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