While the United States is starting the long road to changes in our biotech regulatory system, other countries are also working on their regulatory processes. Coincidentally, the New Zealand Environmental Protection Authority (NZEPA) has an open call for comments closing on 11 Dec 2015 while the US White House Office of Science and Technology Policy (OSTP) has an open call for comments closing on 13 Nov 2015.
We’ve made it easy for everyone to provide comments to the White House, and you can learn more at our post: You can improve US biotechnology regulation.
It seems that the biotech regulations in New Zealand accidentally included older breeding methods. Oops! So the proposed change will exclude from regulation any methods in use in New Zealand on or before 29 July 1998. US laws, while supposedly not process based, generally only apply to “newer” breeding methods such as recombinant DNA technology.
Learn more about the New Zealand biotech regulation update from Grant Jacobs, a computational biologist in New Zealand: Proposed changes to GMO regulation leave major problems unaddressed. In addition, the Science Media Centre in New Zealand collected some comments about the proposed change, and some of their comments could just as easily apply in the US.
There are a few problems with how we define biotechnology in the United States that could lead us down strange paths like what happened in New Zealand.
- Many different terms are used by different groups and agencies.
- There are no really good definitions that everyone can point to.
- Most definitions don’t mention synthetic biology. There’s an ongoing debate on whether synthetic biology really a separate thing or if it fits under the biotechnology umbrella.
- Likewise, most definitions don’t provide for newer technologies such as gene editing. Do they fit under the biotechnology umbrella?
- Lastly, what counts as a GMO is subjective. What if researchers used newer breeding methods but the only change in the final organism was a deletion that could have happened through radiation mutagenesis? What about crops with bacterial DNA that arrived there through natural processes? Or crops whose genomes have large amounts of ancient viral DNA? What about gene transfer that occurs along grafting sites? Genetic engineering that uses only genes from the same species, including RNAi? Biotechnologies are largely based on natural processes and nature doesn’t care about fitting things into neat little boxes for the purposes of regulation.
Biotech definitions in the US
To emphasize the desperate need for a cohesive definition of biotechnology and for some consistency in what terms are used, I’ve collected some of the definitions used by the agencies in the US regulatory system, plus a few others for comparison.
Many of these follow the model of a statement then a list of methods, a model recommended by the OECD. The problem of putting the lists in regulations, though, is that it’s notoriously difficult to change regulations, and we know that technologies are advancing all the time.
Share your comments with the White House on how we can develop better definitions and other improvements to biotech regulation and how the regulatory agencies talk about biotech.
- Coordinated Framework for Regulation of Biotechnology
- Intergeneric Organism (New Organism). Those organisms deliberately formed to contain an intergeneric combination of genetic material; excluded are organisms that have resulted from the addition of intergeneric materials that is well characterized and contains only non-coding regulatory regions such as operators, promoters, origins of replication, terminators and ribosome binding regions.
- “Well-characterized and contains only non-coding regulatory regions” means that the producer of the microorganism can document the following:
- The exact nucleotide base sequence of the regulatory region and any inserted flanking nucleotides;
- The regulatory region and any inserted flanking nucleotides do not code independently for a protein, peptide of functional RNA molecules;
- The regulatory region solely controls the activity of other sequences that code for protein or peptide molecules or act as recognition sites for the initiation of nucleic acid or protein synthesis.
- EPA regulations
- Conventional breeding of plants means the creation of progeny through either: The union of gametes, i.e., syngamy, brought together through processes such as pollination, including bridging crosses between plants and wide crosses, or vegetative reproduction. It does not include use of any of the following technologies: Recombinant DNA; other techniques wherein the genetic material is extracted from an organism and introduced into the genome of the recipient plant through, for example, micro-injection, macro-injection, micro-encapsulation; or cell fusion.
- Recombinant DNA means the genetic material has been manipulated in vitro through the use of restriction endonucleases and/or other enzymes that aid in modifying genetic material, and subsequently introduced into the genome of the plant. A plant-incorporated protectant is exempt if all of the following conditions are met: The genetic material that encodes the pesticidal substance or leads to the production of the pesticidal substance is from a plant that is sexually compatible with the recipient plant and the genetic material has never been derived from a source that is not sexually compatible with the recipient plant.
- USDA APHIS regulations
- Regulated article. Any organism which has been altered or produced through genetic engineering, if the donor organism, recipient organism, or vector or vector agent belongs to any genera or taxa designated in § 340.2 and meets the definition of plant pest, or is an unclassified organism and/or an organism whose classification is unknown, or any product which contains such an organism, or any other organism or product altered or produced through genetic engineering which the Administrator, determines is a plant pest or has reason to believe is a plant pest. Excluded are recipient microorganisms which are not plant pests and which have resulted from the addition of genetic material from a donor organism where the material is well characterized and contains only non-coding regulatory regions.
- Genetic engineering. The genetic modification of organisms by recombinant DNA techniques.
- FDA guidance
- Bioengineered plant means a recombinant-DNA plant. As used by Codex Alimentarius, “recombinant-DNA plant” means a plant in which the genetic material has been changed through in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acids into cells or organelles. [Kudos to FDA for trying to use an already established definition!]
- Bioengineered plants are also referred to as “biotechnology-derived plants” in the Office of Science and Technology Policy Federal Register notice (67 FR 50578, Aug. 2, 2002), and as “recombinant-DNA plants” by the Codex Alimentarius, in “Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants” (CAC/GL 45-2003).
- Codex Alimentarius (United Nations) included here because it was mentioned by the FDA definition
- Recombinant-DNA Plant. Means a plant in which the genetic material has been changed through in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles.
- Conventional Counterpart. Means a related plant variety, its components and/or products for which there is experience of establishing safety based on common use as food.
- NIH guidelines
- In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as:
- (i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;
- (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or
- (iii) molecules that result from the replication of those described in (i) or (ii) above.
- In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as:
- USDA Organic regulations
- Excluded methods. A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture.
- The Non-GMO Project’s definitions for comparison (this organization provides a voluntary non-GMO label for a fee)
- Genetically Modified or Genetic Modification. A term referring to products or processes employing gene splicing, gene modification, recombinant DNA technology, or transgenic technology, and referring to products of the gene-splicing process, either as inputs or as process elements.
- Non GMO. A plant, animal, or other organism or derivative of such an organism whose genetic structure has not been altered by gene splicing. A process or product that does not employ GM processes or inputs. Cloned animals and their progeny are considered GM, as are Synthetically Modified Organisms.
- Synthetically Modified Organism or SMO. An organism with synthetically created genes that come from a process known as ‘synthetic biology’. Input from SMOs, when used as inputs or as process elements in the creation of substances or materials, is considered to be part of the SMO itself for the purpose of this Standard.
- The Biotechnology Industry Organization (this is a trade group for biotech companies) paints a much broader definition
- At its simplest, biotechnology is technology based on biology – biotechnology harnesses cellular and biomolecular processes to develop technologies and products that help improve our lives and the health of our planet. We have used the biological processes of microorganisms for more than 6,000 years to make useful food products, such as bread and cheese, and to preserve dairy products.