Synthetic Biology Policy

Changing policies against synthetic biology!


Organic Regulations Against Synthetic Biology

United States Department of Agriculture (USDA) organic regulation 7CFR 205.601 describes approved characteristics and techniques for bed mulches used in organic agriculture. The excluded methods section of this regulation states that “organisms and feedstocks must not be derived from excluded methods. Excluded methods as defined by the organic standards include the following:

“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.”

This policy presents a significant barrier to implementation of biodegradable films in organic farming. In speaking with growers and experts in the field of film development, we were informed that polyethylene (PE) and other petroleum-derived films are the only agricultural films offered for organic farming. These films must be disposed of after each growing season adding to the continuously mounting issue of plastic waste.

We see that this an obvious place for intervention via Bioengineering. Our design involves the use of synthetic biology (DNA technology) to introduce genes into our naturally occurring bacterial cellulose that would allow entirely bio-based products to supply these desired qualities as opposed to accepted petroleum derivatives.

The prohibition of DNA technology in the development of biodegradable agricultural films further stigmatizes this approach and places us even further from a long term solution: zero plastic waste. This policy insinuates that the USDA places priority on adhering to the negative stigma surrounding genetically modified organisms above the issues of countering global warming, plastic waste, and use of carcinogenic materials.


Presenting Our Defense

During an interview with Dr. Carol Shennan conducted with the Human Practices team, Shennan recommended that we talk to the National Organic Standards Board (NOSB) about policies designed to incentive a shift toward sustainable farming while addressing the USDA organic regulation 7CFR 205.601. The NOSB is a USDA Federal Advisory Board composed of volunteers from the organic community [1]. The NOSB votes on policies related to organic farming and recommends such policies to the US Secretary of Agriculture.

To assess how 7CFR 205.601 affects our project, we contacted Devon Pattillo, an agricultural marketing specialist at the NOSB. Pattillo invited our team to present oral comments to the NOSB Meeting on October 20, 2020 to discuss our concerns with this regulation (We are listed on page 3 of the NOSB schedule).

Allie Jorgenson, a member of our team, presented our project and argument against the USDA regulation 7CFR 205.601 to the NOSB. We emphasized how the exclusion of methods like recombinant DNA technology in film production inherently supports the use of petroleum-based films, and prevents any further development of a sustainable alternative. By attending this meeting our team hoped to hear a policy maker’s perspective on why genetic engineering is disallowed in organic agriculture, and if its disuse simply comes down to an ethical argument.

The following oral comment was presented at the NOSB meeting on October 20, 2020:

"My name is Alicia Jorgenson and I am on the University of California, Santa Cruz’s 2020 iGEM team. iGEM stands for International Genetically Engineered Machine and it is a global non-profit organization that tackles humanitarian issues through the use of synthetic biology and biotechnology.

Traditional microplastic forming polyethylene films are allowed in organic farming while films that biodegrade and replenish the soil are prohibited solely because they are produced through recombinant DNA technology. USDA organic regulation 7 CFR.205.2 states that organisms and feedstock must not be derived from excluded methods, which include recombinant DNA technology. To measure the safety of a product based upon its method of production says nothing about the end product and everything about that method. The exclusion of recombinant DNA technology implies a bias towards that technology though there is no apparent rationale as to why the NOSB believes organic farming and recombinant DNA technology are incompatible. This exclusion supports a technology that promotes cancer and global warming in order to support an ethical stand against genetic engineering.

We understand that products of GMOs are excluded due to the potential carry over of modified DNA into the environment. Clearly, a validation process must be developed to ensure that modified DNA is not present in the film or the degradation product. Through prohibiting products of recombinant DNA technology, the NOSB inherently supports the use of non-sustainable petroleum based films and stands in the way of development of sustainable alternatives to toxic PE films.

We are developing a bacterial cellulose based thermoplastic bed mulch film produced by the recombinant kombucha bacterium, K.rhaeticus. Furthermore, each of the components of our plastic will include only: proteins, carbohydrates, fatty acids, and lipid products, all of which are working within our bodies at all times. These components may be synthesized and expressed through recombinant DNA technology, though our final product will include no intact DNA. Curing methods may include UV or gamma radiation, temperature exposure, or enzymatic degradation.

In accordance with the European standard (EN17033), all of these biobased materials are fully field compostable, and reduce the threat to people or the environment posed by current methods. We see no reason why recombinant DNA technology is incompatible with organic farming as both practices can be used to the advantage of humankind in a clean and sustainable fashion. Thus, we ask that the board reevaluate recombinant DNA technology as a viable method of mulch production. I thank the board for its consideration."

In response to this comment, a board member asked if there are any current 100% bio-based films on the market that are produced through the use of recombinant DNA technology. Currently, the starch and cellulose based prototype films are not 100% bio-based, as they include additives such as coloring agents, lubricants and nucleating agents (or chemical additives that help with the growth of crystals in polymer melts) [2].

We explained how current biodegradable films are not elastic enough, making many growers disinterested in such films. In our design, we wanted to increase flexibility of the film to adhere to the needs of growers. The base of the plastic must be modified by addition of a plasticizer via genetic engineering. This board member appeared interested in whether or not the production of a 100% bio-based mulch using recombinant DNA technology is even possible. Although this member was not initially receptive, we see this inquiry as a chance for productive conversation in the future to push for the consideration of more sustainable methods in agriculture.

A second board member stated that the NOSB is not responsible for deciding measures like this. Amendments to certain organic regulations are decided at a federal level, i.e the USDA. Although this may be true, the NOSB recommends policies and policy amendments to the Secretary of Agriculture. If the Board votes on the enactment or amendment of a policy, they notify the USDA. This comment, therefore, was not too constructive in meeting our team’s agenda.

A third board member, Mindee Jeffery, stated that the reasoning for such excluded methods in 7CFR 205.601 is public record. She suggested that our team search online for the explanation behind this regulation. Our team reached out to that board member directly to inquire where these records are found because our team could not locate the information through a simple Google search. When looking for a way to contact Ms. Jeffrey, we stumbled upon a project she is a part of called Non-GMO project. Learning this proved the interests of the USDA against GMO production as a whole. Our conversation with the NOSB further emphasizes the need for discussion about the benefits of GMOs with government officials to promote overall literacy on the topic and help lessen the public fear surrounding genetically modified organisms in both food and products.

The NOSB Materials Committee is set to deliberate on 7CFR 205.601 on October 30, 2020. Though it seems that the policy will not be amended, our team is appreciative of the opportunity to meet with the NOSB and discuss the regulation directly. We hope to continue fighting for the interests of organic farmers and the need for biodegradable plastic mulches.