Agricultural Marketing Service Published on Agricultural Marketing Service (http://www.ams.usda.gov) Home > Proposed Rule Questions Under Consideration Proposed Rule Questions Under Consideration [1]

The Society for In Vitro Biology (SIVB), formerly the Tissue Culture Association, is a professional society devoted to fostering the exchange of knowledge of in vitro biology of cells, tissues and organs from both plant and animals (including humans). The focus is on biological research, development, and applications of significance to science and society.  The SIVB membership is composed of academics, ranging from professors to students, industry members and other interested expert members that work in the area of tissue culture.  SIVB members have played leading roles in the development, safety evaluation, and deployment of GE crops; therefore, the SIVB membership counts with unparalleled expertise on the topic.   Even so, AMS is requesting answers to questions that not biological in nature, and which consequently, SIVB lacks the proper expertise to answer, so we did not provide answers to all the questions.

  1. What terms should AMS consider interchangeable with ‘bioengineering’? (Sec. 291(1))

SIVB Response:

genetic engineering
gene splicing
GMO

Context:  The disclosure standard would be a mechanism to inform consumers about their food.  AMS is considering the advantages and disadvantages of allowing the use of other terms to provide for disclosure. 

2. Which breeding techniques should AMS consider conventional breeding? (Sec. 291(1)(B))

inbred line development apospory parthenogenesis
haploid induction  autopolyploid early generation selection
diploidization  backcross breeding natural selection
micropropagation  backcross-pedigree breeding phenotypic selection
embryo rescue  isogenic line development polyploidy breeding
sport selection  restoration backcrossing progeny testing
plant breeding  cytoplasmic male sterility pure line breeding
animal breeding  plant and animal domestication random mating
plant hybridization  haploid breeding reciprocal crosses
animal hybridization  specific combining ability reciprocal recurrent selection
plant inbreeding  general combining ability recurrent parent
animal inbreeding  dialle crossing non-recurrent parent
mutation breeding (animal & plant)  diploidization phenotypic recurrent breeding
irradiation breeding  double-cross hybrids genotypic recurrent breeding
plant selection  single-cross hybrids roguing
animal selection  chromosome doubling seed certification
plant varietial selection  genetic male sterility seed production
animal varietal selection  hybrid vigor somatic hybridization
pedigree breeding  inbreeding depression specific combining ability
bulk population breeding introgression synthetic cultivar
asexual breeding  anther culture synthetic cultivar development
alien cytoplasm  mass selection tester parent
alloploid  ear-to-row breeding method transgressive segregation
amphidiploid breeding  open pollinated disease resistance
apomixis  recurrent mass selection insect resistance
virus resistance  somaclonal variation heterosis
interspecific hybridization
  1. Which modifications should AMS consider to be found in nature? (Sec. 291(1)(B))

SIVB Response:  Examples can be found in nature that has resulted from all of the breeding methods mentioned in 2.  Many of these occurred during the process of domestication of plants and animals for agricultural use by humans.  Horizontal gene transfer has been found to be ubiquitous in nature and thus can be considered as a naturally occurring event.

Sample references:

  • Bergthorsson U, KL Adams, B Thomason, & JD Palmer 2003. Widespread horizontal transfer of mitochondrial genes in flowering plants. Nature, 424:197-201.
  • El Baidouri M, M-C Carpentier, R Cooke, D Gao, E Lasserre, C Llauro, M Mirouze, N Picault, SA Jackson and O Panaud. Widespread and frequent horizontal transposable elements in plants.  Genome Research  24: 831-838
  • Geering ADW, F Maumus, D Copetti, N Choisne, DJ Zwicki, M Zytnicki, AR McTaggart, S Scalabrin, S Vezzulli, RA Wing, H Quesneville and P-Y Teycheyney.   Endogenous florendoviruses are a major components of plant genomes and hallmarks of virus evolution.  Nature Communications 5(5269) doi:10.1038/ncomms6269.
  • Kyndt T, D Quispe, H Zhai, R Jarrett, M Ghislain, Q Liu, G Gheysen, and JF Kreuze.   The genome of cultivated sweet potato contains Agrobacterium T-DNAs with expressed genes:  an example of a naturally transgenic food crop.  Proc. Natl. Acad Sci USA  112:5844-5849
  • Liu et al 2012. Evolutionary force of AT-rich repeats to trap genomic and episomal DNAs into the rice genome: lessons from endogenous pararetrovirus. Plant Journal 72:817-82
  • Staginnus et al. 2007 Endogenous pararetroviral sequences in tomato (Solanum lycopersicum) and related species BMC Plant Biology7:24   
  1. Will AMS require disclosure for food that contains highly refined products, such as oils or sugars derived from bioengineered crops? (Sec. 291(1)(A))

SIVB Response:  If it cannot be reliably and easily tested in a lab, it should not be disclosed.  At the end of the day, a sugar or oil molecule from a bioengineered plant is indistinguishable from that of a non-bioengineered plant. 

  1. How should AMS craft language in the regulations acknowledging that animals consuming bioengineered feed are exempt from the disclosure requirements as bioengineered solely because they fed on bioengineered feed? (Sec. 293(b)(2)(A))

SIVB response:  “Animals or animal products fed any amount of bioengineered feeds do not become bioengineered and are thus exempt from the disclosure requirements as bioengineered.”

  1. What is the amount of a bioengineered substance present in a food that should make it be considered bioengineered? (Sec. 293(b)(2)(B))

SIVB response: AMS already has standards that can be used for the purpose, namely the organic labeling standards.  It is incumbent upon AMS to ensure both technologies are treated equally in it’s rule making.

Each of the existing organic labeling categories (100% organic, organic, and made with organic ingredients) should have a counterpart in bioengineered, and with the same thresholds.

When setting thresholds, it is important to remember that the smaller the threshold, the larger the amount of sampling that must be done to get statistically valid measurements. 

  1. Should AMS consider more than one disclosure category? (Sec. 293(b)(2)(D))

SIVB Response:  Yes, to be consistent with the organic standards.  AMS already has standards that can be used for the purpose, namely the organic labeling standards, and it has multiple categories in it.  It is incumbent upon AMS to ensure both technologies are treated equally in its rule making.

For ingredients that may be seasonably present, a ‘May have’ bioengineered ingredients label to any one ingredient that qualifies as a bioengineered ingredient under #8 above.  AMS should be cognizant that repeated testing of each batch of food is unnecessarily expensive. 

  1. What other factors or conditions should AMS consider under which a food is considered a bioengineered food? (Sec. 293(b)(2)(C))

SIVB response:  If the final rDNA or its protein is in the final product, and is present over the threshold from #8, it should be considered covered, otherwise it is not.

  1. Could AMS consider whether a type of food is considered a bioengineered food under the determination process? (Sec. 293(b)(2)(C))

SIVB response:  If the final rDNA or its protein is in the final product, and is present over the threshold from #8, it should be considered covered, otherwise it is not

  1. If a manufacturer chooses to use text to disclose a bioengineered food, what text should AMS require for a text disclosure? (Sec. 293(b)(2)(D))

SIVB response:  Should be parallel to organic disclosure.

However, the GMO-free label should be explicity prohibited whenever the ingredient has no bioengineered counterpart, as such labels are very misleading. 

  1. If a manufacturer chooses to use text to disclose a bioengineered food, what text should AMS require for a text disclosure? (Sec. 293(b)(2)(D))

SIVB response:  *Either nothing should be on the label, or “May be produced with Genetic Engineering” should be included on all labels.